Trial Outcomes & Findings for Myocardial Perfusion MRI (NCT NCT01490294)

NCT ID: NCT01490294

Last Updated: 2014-05-22

Results Overview

Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 232 participants
• Primary outcome timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration
• Results posted on: 2014-05-22

Participant Flow

Participant milestones

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Overall Study STARTED	58	60	59	55
Overall Study Participant Received Treatment	54	60	58	54
Overall Study COMPLETED	53	60	58	54
Overall Study NOT COMPLETED	5	0	1	1

Reasons for withdrawal

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Overall Study Prematurely discontinuation	4	0	1	1
Overall Study Adverse Event	1	0	0	0

Baseline Characteristics

Myocardial Perfusion MRI

Baseline characteristics by cohort

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=54 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=60 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=58 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=54 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Total n=226 Participants Total of all reporting groups
Age, Continuous	62.0 Years n=5 Participants	61.5 Years n=7 Participants	64.5 Years n=5 Participants	61.0 Years n=4 Participants	62.0 Years n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	70 Participants n=21 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	41 Participants n=7 Participants	41 Participants n=5 Participants	35 Participants n=4 Participants	156 Participants n=21 Participants
History of myocardial infarction No	34 Participants n=5 Participants	42 Participants n=7 Participants	43 Participants n=5 Participants	37 Participants n=4 Participants	156 Participants n=21 Participants
History of myocardial infarction Yes	20 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	67 Participants n=21 Participants
History of myocardial infarction Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: Per protocol set (PPS)

Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=396 Regional assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=513 Regional assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions Disagreement	58.8 Percent regional assessments	44.1 Percent regional assessments	36.7 Percent regional assessments	40.3 Percent regional assessments
Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions Agreement	41.2 Percent regional assessments	55.9 Percent regional assessments	63.3 Percent regional assessments	59.7 Percent regional assessments

PRIMARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: Per protocol set (PPS)

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2112 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=2736 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments Disagreement	51.1 Percent segmental assessment	39.4 Percent segmental assessment	34.5 Percent segmental assessment	34.1 Percent segmental assessment
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments Agreement	48.9 Percent segmental assessment	60.6 Percent segmental assessment	65.5 Percent segmental assessment	65.9 Percent segmental assessment

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=132 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=171 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=153 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=153 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions Disagreement	48.5 Percent regional assessments	39.2 Percent regional assessments	35.2 Percent regional assessments	37.7 Percent regional assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions Agreement	51.5 Percent regional assessments	60.8 Percent regional assessments	64.8 Percent regional assessments	62.3 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=704 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=912 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments Disagreement	39.3 Percent segmental assessments	30.4 Percent segmental assessments	28.7 Percent segmental assessments	33.3 Percent segmental assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments Agreement	60.7 Percent segmental assessments	69.6 Percent segmental assessments	71.3 Percent segmental assessments	66.7 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "scar" in at least 1 region in SPECT were included.

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "scar" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=48 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=72 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=42 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=96 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions Disagreement	81.3 Percent regional assessments	80.6 Percent regional assessments	83.3 Percent regional assessments	86.5 Percent regional assessments
Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions Agreement	18.8 Percent regional assessments	19.4 Percent regional assessments	16.7 Percent regional assessments	13.5 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "scar" in at least 1 segment in SPECT were included.

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "scar" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "scar". The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by at least 1 blinded reader.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=129 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=147 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=111 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=195 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments Disagreement	88.4 Percent segmental assessments	85.7 Percent segmental assessments	82.0 Percent segmental assessments	90.8 Percent segmental assessments
Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments Agreement	11.6 Percent segmental assessments	14.3 Percent segmental assessments	18.0 Percent segmental assessments	9.2 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "scar" in at least 1 region in SPECT were included.

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "scar" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "scar". The number of regional assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=11 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=25 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=17 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=21 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions Disagreement	81.8 Percent regional assessments	76.0 Percent regional assessments	76.5 Percent regional assessments	85.7 Percent regional assessments
Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions Agreement	18.2 Percent regional assessments	24.0 Percent regional assessments	23.5 Percent regional assessments	14.3 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "scar" in at least 1 segment in SPECT were included.

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "scar" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of "scar". The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=22 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=46 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=33 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=50 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments Disagreement	86.4 Percent segmental assessments	84.8 Percent segmental assessments	69.7 Percent segmental assessments	88.0 Percent segmental assessments
Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments Agreement	13.6 Percent segmental assessments	15.2 Percent segmental assessments	30.3 Percent segmental assessments	12.0 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "ischemia" in at least 1 region in SPECT were included.

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "ischemia".The number of regional assessments is defined as the number of regions with diagnosis "ischemia" assessed by at least 1 blinded reader.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=198 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=228 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=216 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=213 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions Disagreement	87.9 Percent regional assessments	69.3 Percent regional assessments	64.4 Percent regional assessments	60.6 Percent regional assessments
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions Agreement	12.1 Percent regional assessments	30.7 Percent regional assessments	35.6 Percent regional assessments	39.4 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "ischemia" in at least 1 segment in SPECT were included.

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "ischemia". The number of segmental assessments is defined as the number of segments with diagnosis "ischemia" assessed by at least 1 blinded reader.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=513 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=561 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=567 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=588 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments Disagreement	91.8 Percent segmental assessment	77.5 Percent segmental assessment	74.3 Percent segmental assessment	68.9 Percent segmental assessment
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments Agreement	8.2 Percent segmental assessment	22.5 Percent segmental assessment	25.7 Percent segmental assessment	31.1 Percent segmental assessment

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "ischemia" in at least 1 region in SPECT were included.

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "ischemia". The number of regional assessments is defined as the number of regions with diagnosis "ischemia" assessed by the investigator.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=74 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=96 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=89 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=90 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions Disagreement	63.5 Percent regional assessments	61.5 Percent regional assessments	48.3 Percent regional assessments	46.7 Percent regional assessments
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions Agreement	36.5 Percent regional assessments	38.5 Percent regional assessments	51.7 Percent regional assessments	53.3 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only patients with the finding "ischemia" in at least 1 segment in SPECT were included.

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "ischemia". The number of segmental assessments is defined as the number of segments with diagnosis "ischemia" assessed by the investigator.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=186 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=222 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=221 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=232 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments Disagreement	77.4 Percent segmental assessments	66.7 Percent segmental assessments	58.4 Percent segmental assessments	58.2 Percent segmental assessments
Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments Agreement	22.6 Percent segmental assessments	33.3 Percent segmental assessments	41.6 Percent segmental assessments	41.8 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=396 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=513 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions Disagreement	67.4 Percent regional assessments	57.3 Percent regional assessments	46.8 Percent regional assessments	53.0 Percent regional assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions Agreement	32.6 Percent regional assessments	42.7 Percent regional assessments	53.2 Percent regional assessments	47.0 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2112 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=2736 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments Disagreement	53.8 Percent segmental assessment	42.7 Percent segmental assessment	36.8 Percent segmental assessment	37.3 Percent segmental assessment
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments Agreement	46.2 Percent segmental assessment	57.3 Percent segmental assessment	63.2 Percent segmental assessment	62.7 Percent segmental assessment

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=132 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=171 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=159 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=159 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions Disagreement	52.3 Percent regional assessments	49.1 Percent regional assessments	42.1 Percent regional assessments	46.5 Percent regional assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions Agreement	47.7 Percent regional assessments	50.9 Percent regional assessments	57.9 Percent regional assessments	53.5 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=704 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=912 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments Disagreement	40.9 Percent segmental assessments	33.0 Percent segmental assessments	31.1 Percent segmental assessments	35.6 Percent segmental assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments Agreement	59.1 Percent segmental assessments	67.0 Percent segmental assessments	68.9 Percent segmental assessments	64.4 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=396 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=513 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions Disagreement	66.2 Percent regional assessments	53.8 Percent regional assessments	51.4 Percent regional assessments	53.5 Percent regional assessments
Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions Agreement	33.8 Percent regional assessments	46.2 Percent regional assessments	48.6 Percent regional assessments	46.5 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2112 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=2736 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments Disagreement	48.5 Percent segmental assessments	41.2 Percent segmental assessments	35.6 Percent segmental assessments	35.3 Percent segmental assessments
Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments Agreement	51.5 Percent segmental assessments	58.8 Percent segmental assessments	64.4 Percent segmental assessments	64.7 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2112 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=2736 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments Missing	1.8 Percentage of segments with artifacts	1.4 Percentage of segments with artifacts	2.8 Percentage of segments with artifacts	1.5 Percentage of segments with artifacts
Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments No	66.3 Percentage of segments with artifacts	62.7 Percentage of segments with artifacts	62.1 Percentage of segments with artifacts	66.3 Percentage of segments with artifacts
Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments Yes	31.9 Percentage of segments with artifacts	35.9 Percentage of segments with artifacts	35.0 Percentage of segments with artifacts	32.2 Percentage of segments with artifacts

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=704 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=912 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments No	85.5 Percentage of segments with artifacts	85.3 Percentage of segments with artifacts	81.5 Percentage of segments with artifacts	83.5 Percentage of segments with artifacts
Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments Yes	14.5 Percentage of segments with artifacts	14.7 Percentage of segments with artifacts	17.1 Percentage of segments with artifacts	15.8 Percentage of segments with artifacts
Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments Not assessable	0.0 Percentage of segments with artifacts	0.0 Percentage of segments with artifacts	1.4 Percentage of segments with artifacts	0.0 Percentage of segments with artifacts
Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments Not determined	0.0 Percentage of segments with artifacts	0.0 Percentage of segments with artifacts	0.0 Percentage of segments with artifacts	0.7 Percentage of segments with artifacts

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure

Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=162 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=258 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=219 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=291 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses Disagreement	50.6 Percent regional assessments	48.1 Percent regional assessments	38.8 Percent regional assessments	32.3 Percent regional assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses Agreement	49.4 Percent regional assessments	51.9 Percent regional assessments	61.2 Percent regional assessments	67.7 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure

MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=54 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=86 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=73 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=97 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI) " (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) Disagreement	53.7 Percent regional assessments	40.7 Percent regional assessments	60.3 Percent regional assessments	56.7 Percent regional assessments
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI) " (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) Agreement	46.3 Percent regional assessments	59.3 Percent regional assessments	39.7 Percent regional assessments	43.3 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure

For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=207 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=315 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=261 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=324 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions Disagreement	62.8 Percent regional assessments	51.4 Percent regional assessments	53.6 Percent regional assessments	40.7 Percent regional assessments
Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions Agreement	37.2 Percent regional assessments	48.6 Percent regional assessments	46.4 Percent regional assessments	59.3 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=132 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=171 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=159 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=159 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions Disagreement	62.1 Percent regional assessments	60.8 Percent regional assessments	59.1 Percent regional assessments	66.0 Percent regional assessments
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions Agreement	37.9 Percent regional assessments	39.2 Percent regional assessments	40.9 Percent regional assessments	34.0 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=704 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=912 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments Disagreement	69.6 Percent segmental assessments	57.0 Percent segmental assessments	48.9 Percent segmental assessments	49.4 Percent segmental assessments
Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments Agreement	30.4 Percent segmental assessments	43.0 Percent segmental assessments	51.1 Percent segmental assessments	50.6 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=396 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=513 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=477 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions Disagreement	56.3 Percent regional assessments	55.2 Percent regional assessments	49.1 Percent regional assessments	58.3 Percent regional assessments
Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions Agreement	43.7 Percent regional assessments	44.8 Percent regional assessments	50.9 Percent regional assessments	41.7 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2112 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=2736 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments Disagreement	53.0 Percent segmental assessments	46.3 Percent segmental assessments	41.8 Percent segmental assessments	43.7 Percent segmental assessments
Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments Agreement	47.0 Percent segmental assessments	53.7 Percent segmental assessments	58.2 Percent segmental assessments	56.3 Percent segmental assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated ("normal/diseased" was defined by central reading of SPECT).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=44 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=57 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=53 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=53 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Signal Intensity (SIrel) Based on Segments Normal segment	0.768 Signal intensity Standard Deviation 2.0791	0.625 Signal intensity Standard Deviation 0.3992	0.708 Signal intensity Standard Deviation 0.8233	0.615 Signal intensity Standard Deviation 0.2428
Signal Intensity (SIrel) Based on Segments Disease segment	0.732 Signal intensity Standard Deviation 1.5511	0.603 Signal intensity Standard Deviation 0.5428	0.813 Signal intensity Standard Deviation 2.0755	0.584 Signal intensity Standard Deviation 0.2424

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: PPS

"Upslope" is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in "Units/sec". The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference ("normal/diseased" was defined by central reading of SPECT).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=44 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=57 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=53 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=53 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Upslope Based on Segments Normal segment	11.44 Units/sec Standard Deviation 7.389	18.18 Units/sec Standard Deviation 9.850	27.49 Units/sec Standard Deviation 17.704	31.31 Units/sec Standard Deviation 24.339
Upslope Based on Segments Disease segment	11.41 Units/sec Standard Deviation 6.730	17.90 Units/sec Standard Deviation 8.587	22.13 Units/sec Standard Deviation 13.997	26.93 Units/sec Standard Deviation 19.890

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes

Population: PPS

"Time to peak" is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=44 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=57 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=53 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=53 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Time to Peak Based on Segments Normal segment	12.43 Seconds Standard Deviation 4.241	13.83 Seconds Standard Deviation 4.407	13.87 Seconds Standard Deviation 4.636	15.34 Seconds Standard Deviation 4.403
Time to Peak Based on Segments Disease segment	12.11 Seconds Standard Deviation 3.796	13.67 Seconds Standard Deviation 4.104	15.75 Seconds Standard Deviation 4.982	16.34 Seconds Standard Deviation 4.519

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding "scar" in at least 1 segment in SPECT were included.

Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis "scar" derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis "scar" assessed by at least 1 blinded reader.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=48 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=72 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=42 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=96 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 5 min DE	0.0 Percent regional assessments	1.4 Percent regional assessments	14.3 Percent regional assessments	36.5 Percent regional assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 10 min DE	0.0 Percent regional assessments	5.6 Percent regional assessments	19.0 Percent regional assessments	33.3 Percent regional assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 15 min DE	0.0 Percent regional assessments	2.8 Percent regional assessments	19.0 Percent regional assessments	38.5 Percent regional assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 20 min DE	0.0 Percent regional assessments	2.8 Percent regional assessments	19.0 Percent regional assessments	39.6 Percent regional assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding "scar" in at least 1 segment in SPECT were included.

Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis "scar" derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by at least 1 blinded reader.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=129 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=147 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=111 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=195 Segmental Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 5 min DE	0.0 Percent segmental assessments	0.7 Percent segmental assessments	18.9 Percent segmental assessments	31.3 Percent segmental assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 10 min DE	0.0 Percent segmental assessments	2.7 Percent segmental assessments	20.7 Percent segmental assessments	28.7 Percent segmental assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 15 min DE	0.0 Percent segmental assessments	1.4 Percent segmental assessments	20.7 Percent segmental assessments	35.4 Percent segmental assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 20 min DE	0.0 Percent segmental assessments	1.4 Percent segmental assessments	20.7 Percent segmental assessments	36.4 Percent segmental assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding "scar" in at least 1 region in SPECT were included.

Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis "scar" derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis "scar" assessed by the investigator.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=16 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=24 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=14 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=32 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 5 min DE	6.3 Percent regional assessments	4.2 Percent regional assessments	21.4 Percent regional assessments	25.0 Percent regional assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 10 min DE	6.3 Percent regional assessments	4.2 Percent regional assessments	28.6 Percent regional assessments	37.5 Percent regional assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 15 min DE	6.3 Percent regional assessments	12.5 Percent regional assessments	28.6 Percent regional assessments	37.5 Percent regional assessments
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions region - 20 min DE	6.3 Percent regional assessments	4.2 Percent regional assessments	21.4 Percent regional assessments	37.5 Percent regional assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Only participants with the finding "scar" in at least 1 segment in SPECT were included.

Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis "scar" derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=43 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=49 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=37 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=65 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 5 min DE	4.7 Percent segmental assessment	2.0 Percent segmental assessment	21.6 Percent segmental assessment	23.1 Percent segmental assessment
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 10 min DE	7.0 Percent segmental assessment	2.0 Percent segmental assessment	24.3 Percent segmental assessment	30.8 Percent segmental assessment
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 15 min DE	9.3 Percent segmental assessment	6.1 Percent segmental assessment	18.9 Percent segmental assessment	32.3 Percent segmental assessment
Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments segment - 20 min DE	2.3 Percent segmental assessment	2.0 Percent segmental assessment	18.9 Percent segmental assessment	30.8 Percent segmental assessment

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. The evaluation included only participants with delayed enhancement in at least 1 segment ( PPS) based on the assessment of at least one blinded reader.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=14 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=40 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=49 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) Poor	5 Delayed enhancement assessments	12 Delayed enhancement assessments	11 Delayed enhancement assessments	8 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) Satisfactory	0 Delayed enhancement assessments	1 Delayed enhancement assessments	6 Delayed enhancement assessments	15 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) good/excellent	0 Delayed enhancement assessments	1 Delayed enhancement assessments	23 Delayed enhancement assessments	26 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=10 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=13 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=16 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Participants	4 Participants	4 Participants	2 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	1 Participants	2 Participants	8 Participants	10 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Poor	1 Participants	4 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=3 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=20 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=40 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=51 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Poor	3 Delayed enhancement assessments	11 Delayed enhancement assessments	14 Delayed enhancement assessments	14 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	5 Delayed enhancement assessments	3 Delayed enhancement assessments	12 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	4 Delayed enhancement assessments	23 Delayed enhancement assessments	25 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=14 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Poor	1 Participants	6 Participants	2 Participants	3 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	2 Participants	3 Participants	3 Participants	2 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	2 Participants	5 Participants	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=3 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=15 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=44 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=56 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Poor	3 Delayed enhancement assessments	8 Delayed enhancement assessments	15 Delayed enhancement assessments	17 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	4 Delayed enhancement assessments	6 Delayed enhancement assessments	11 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	3 Delayed enhancement assessments	23 Delayed enhancement assessments	28 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=12 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Poor	2 Participants	5 Participants	2 Participants	4 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	2 Participants	4 Participants	6 Participants	1 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	1 Participants	3 Participants	9 Participants	12 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=19 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=44 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=60 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Poor	5 Delayed enhancement assessments	11 Delayed enhancement assessments	15 Delayed enhancement assessments	18 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	4 Delayed enhancement assessments	10 Delayed enhancement assessments	17 Delayed enhancement assessments
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	4 Delayed enhancement assessments	19 Delayed enhancement assessments	25 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=11 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=15 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=16 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Poor	4 Participants	3 Participants	1 Participants	3 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	1 Participants	5 Participants	5 Participants	0 Participants
Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Participants	3 Participants	9 Participants	13 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=14 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=40 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=49 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Poor	5 Delayed enhancement assessments	11 Delayed enhancement assessments	13 Delayed enhancement assessments	8 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	2 Delayed enhancement assessments	3 Delayed enhancement assessments	20 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	1 Delayed enhancement assessments	24 Delayed enhancement assessments	21 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=10 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=13 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=16 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Poor	2 Participants	3 Participants	3 Participants	4 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Participants	5 Participants	3 Participants	1 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Participants	2 Participants	7 Participants	11 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=4 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=20 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=40 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=51 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Poor	4 Delayed enhancement assessments	13 Delayed enhancement assessments	13 Delayed enhancement assessments	15 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	5 Delayed enhancement assessments	5 Delayed enhancement assessments	15 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	2 Delayed enhancement assessments	22 Delayed enhancement assessments	21 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=14 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Poor	1 Participants	5 Participants	3 Participants	3 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Satisfactory	1 Participants	5 Participants	2 Participants	2 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Good/excellent	3 Participants	4 Participants	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=4 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=15 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=44 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=56 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) Poor	4 Delayed enhancement assessments	11 Delayed enhancement assessments	13 Delayed enhancement assessments	15 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	2 Delayed enhancement assessments	11 Delayed enhancement assessments	16 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	2 Delayed enhancement assessments	20 Delayed enhancement assessments	25 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=12 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=17 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Poor	3 Participants	4 Participants	3 Participants	4 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Satisfactory	1 Participants	5 Participants	4 Participants	1 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Good/excellent	1 Participants	3 Participants	10 Participants	12 Participants

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=19 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=44 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=60 Delayed enhancement assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) Poor	5 Delayed enhancement assessments	12 Delayed enhancement assessments	12 Delayed enhancement assessments	14 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) Satisfactory	0 Delayed enhancement assessments	4 Delayed enhancement assessments	18 Delayed enhancement assessments	25 Delayed enhancement assessments
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Delayed enhancement assessments	3 Delayed enhancement assessments	14 Delayed enhancement assessments	21 Delayed enhancement assessments

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=11 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=15 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=16 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Poor	4 Participants	2 Participants	2 Participants	3 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Satisfactory	1 Participants	5 Participants	3 Participants	1 Participants
Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) Good/excellent	0 Participants	4 Participants	10 Participants	12 Participants

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=91 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=52 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=69 Regional Assessments Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions	—	12.1 Percent regional assessments	21.2 Percent regional assessments	27.5 Percent regional assessments

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=179 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=85 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=126 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments	—	7.3 Percent segmental assessment	27.1 Percent segmental assessment	23.8 Percent segmental assessment

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=12 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=20 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=34 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=23 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments	41.7 Percent segmental assessment	75.0 Percent segmental assessment	82.4 Percent segmental assessment	100.0 Percent segmental assessment

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=5 Regional Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=11 Regional Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=16 Regional Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=14 Regional Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions	20.0 Percent regional assessment	72.7 Percent regional assessment	87.5 Percent regional assessment	92.9 Percent regional assessment

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

Population: PPS. Evaluation included all participants in the per protocol population with an assessment for this outcome measure

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=2112 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=2736 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=2544 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) 5 min DE	23.9 Percent segmental assessment	22.3 Percent segmental assessment	26.7 Percent segmental assessment	26.2 Percent segmental assessment
Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) 10 min DE	25.3 Percent segmental assessment	19.4 Percent segmental assessment	18.2 Percent segmental assessment	22.6 Percent segmental assessment
Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) 15 min DE	20.9 Percent segmental assessment	18.0 Percent segmental assessment	20.7 Percent segmental assessment	24.7 Percent segmental assessment
Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) 20 min DE	19.2 Percent segmental assessment	16.4 Percent segmental assessment	18.7 Percent segmental assessment	21.8 Percent segmental assessment

SECONDARY outcome

Timeframe: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

Population: All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure

Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=704 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=880 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=848 Segmental Assessment Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) 5 min DE	26.8 Percent segmental assessment	24.9 Percent segmental assessment	21.3 Percent segmental assessment	11.7 Percent segmental assessment
Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) 10 min DE	23.3 Percent segmental assessment	21.3 Percent segmental assessment	10.6 Percent segmental assessment	13.8 Percent segmental assessment
Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) 15 min DE	23.7 Percent segmental assessment	19.4 Percent segmental assessment	13.7 Percent segmental assessment	11.9 Percent segmental assessment
Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) 20 min DE	24.9 Percent segmental assessment	22.8 Percent segmental assessment	13.4 Percent segmental assessment	14.2 Percent segmental assessment

SECONDARY outcome

Timeframe: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Population: All participants in FAS with assessment for this outcome measure. Evaluation included all participants in the full analysis population with an assessment for this outcome measure

Outcome measures

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=52 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=60 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=56 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=54 Participants Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) No	86.5 Percentage of participants	76.7 Percentage of participants	76.8 Percentage of participants	85.2 Percentage of participants
Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) Yes	13.5 Percentage of participants	23.3 Percentage of participants	23.2 Percentage of participants	14.8 Percentage of participants

Adverse Events

Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) n=54 participants at risk Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) n=60 participants at risk Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) n=58 participants at risk Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.	Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) n=54 participants at risk Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Cardiac disorders Angina pectoris	1.9% 1/54 • Number of events 1	0.00% 0/60	1.7% 1/58 • Number of events 1	1.9% 1/54 • Number of events 1
Cardiac disorders Atrioventricular block first degree	0.00% 0/54	0.00% 0/60	0.00% 0/58	1.9% 1/54 • Number of events 1
Gastrointestinal disorders Abdominal pain	0.00% 0/54	0.00% 0/60	1.7% 1/58 • Number of events 1	0.00% 0/54
Gastrointestinal disorders Diarrhoea	0.00% 0/54	0.00% 0/60	1.7% 1/58 • Number of events 1	0.00% 0/54
Gastrointestinal disorders Nausea	1.9% 1/54 • Number of events 1	0.00% 0/60	0.00% 0/58	0.00% 0/54
General disorders Asthenia	1.9% 1/54 • Number of events 1	0.00% 0/60	0.00% 0/58	0.00% 0/54
General disorders Chest discomfort	0.00% 0/54	0.00% 0/60	1.7% 1/58 • Number of events 1	0.00% 0/54
General disorders Chills	1.9% 1/54 • Number of events 1	0.00% 0/60	0.00% 0/58	0.00% 0/54
Investigations Electrocardiogram ST segment depression	0.00% 0/54	1.7% 1/60 • Number of events 1	0.00% 0/58	1.9% 1/54 • Number of events 1
Investigations Electrocardiogram T wave inversion	0.00% 0/54	0.00% 0/60	0.00% 0/58	1.9% 1/54 • Number of events 1
Nervous system disorders Dizziness	0.00% 0/54	0.00% 0/60	1.7% 1/58 • Number of events 1	0.00% 0/54
Nervous system disorders Headache	0.00% 0/54	1.7% 1/60 • Number of events 1	0.00% 0/58	1.9% 1/54 • Number of events 1
Nervous system disorders Loss of consciousness	0.00% 0/54	0.00% 0/60	0.00% 0/58	1.9% 1/54 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/54 • Number of events 1	0.00% 0/60	0.00% 0/58	0.00% 0/54

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60