Trial Outcomes & Findings for Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD) (NCT NCT01890421)
NCT ID: NCT01890421
Last Updated: 2018-05-16
Results Overview
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).
COMPLETED
PHASE3
426 participants
0 to 30/40 minute (min) post-injection
2018-05-16
Participant Flow
The study was conducted at 23 study centers in 7 countries (Germany, South Korea, United Kingdom, France, United States, New Zealand and Switzerland), between 19 July 2013 (first subject first visit) and 10 April 2015 (last subject last visit).
Overall, 456 participants signed the informed consent, of them 19 did not finish their baseline visit (6 screening failure, 13 dropped out), 1 discontinued the study due to an adverse event (AE). A total of 436 participants entered the diagnostic imaging phase, of them 426 were treated with gadobutrol and entered the follow-up phase.
Participant milestones
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Overall Study
STARTED
|
426
|
|
Overall Study
COMPLETED
|
415
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Other reason
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10
|
Baseline Characteristics
Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Baseline characteristics by cohort
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=426 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
297 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
414 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
111 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
310 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Childbearing Potential
Of childbearing potential (only females)
|
20 Count of Participants
n=93 Participants
|
|
Childbearing Potential
No childbearing potential (only females)
|
109 Count of Participants
n=93 Participants
|
|
Childbearing Potential
No childbearing potential (only males)
|
297 Count of Participants
n=93 Participants
|
|
Body Weight
|
79.75 Kilogram (kg)
STANDARD_DEVIATION 16.29 • n=93 Participants
|
|
Height
|
170.99 Centimeter
STANDARD_DEVIATION 9.17 • n=93 Participants
|
|
Body Mass Index
|
27.160 Kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.561 • n=93 Participants
|
|
Country
Germany
|
210 Participants
n=93 Participants
|
|
Country
South Korea
|
108 Participants
n=93 Participants
|
|
Country
Switzerland
|
44 Participants
n=93 Participants
|
|
Country
United States of America
|
31 Participants
n=93 Participants
|
|
Country
United Kingdom
|
28 Participants
n=93 Participants
|
|
Country
France
|
4 Participants
n=93 Participants
|
|
Country
New Zealand
|
1 Participants
n=93 Participants
|
|
Age Categorical
< 45 years
|
60 Count of Participants
n=93 Participants
|
|
Age Categorical
>= 45 to <= 64 years
|
232 Count of Participants
n=93 Participants
|
|
Age Categorical
>= 65 years
|
134 Count of Participants
n=93 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
84.2 mL/min/1.73m^2
STANDARD_DEVIATION 18.37 • n=93 Participants
|
PRIMARY outcome
Timeframe: 0 to 30/40 minute (min) post-injectionPopulation: Full analysis set (FAS): participants who underwent pharmacologic stress and for whom electronic case report form entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=141 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment
Reader 1
|
76.6 Sensitivity %
Interval 68.7 to 83.3
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment
Reader 2
|
65.2 Sensitivity %
Interval 56.8 to 73.1
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment
Reader 3
|
64.5 Sensitivity %
Interval 56.0 to 72.4
|
PRIMARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS: participants who underwent pharmacologic stress and for whom electronic case report form (eCRF) entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for secondary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=108 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment
Reader 1
|
89.8 Sensitivity %
Interval 82.5 to 94.8
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment
Reader 2
|
79.6 Sensitivity %
Interval 70.8 to 86.8
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment
Reader 3
|
78.7 Sensitivity %
Interval 69.8 to 86.0
|
PRIMARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=235 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment
Reader 1
|
85.1 Specificity %
Interval 79.9 to 89.4
|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment
Reader 2
|
92.3 Specificity %
Interval 88.2 to 95.4
|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment
Reader 3
|
91.9 Specificity %
Interval 87.7 to 95.1
|
PRIMARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=268 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment
Reader 1
|
82.8 Specificity %
Interval 77.8 to 87.2
|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment
Reader 2
|
91.0 Specificity %
Interval 87.0 to 94.2
|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment
Reader 3
|
90.7 Specificity %
Interval 86.5 to 93.9
|
PRIMARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=141 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Gadobutrol-enhanced CMRI-Reader 1
|
76.6 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Gadobutrol-enhanced CMRI-Reader 2
|
65.2 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Gadobutrol-enhanced CMRI-Reader 3
|
64.5 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Unenhanced CMRI-Reader 1
|
77.3 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Unenhanced CMRI-Reader 2
|
36.2 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Unenhanced CMRI-Reader 3
|
40.4 Sensitivity %
|
PRIMARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=108 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Gadobutrol-enhanced CMRI-Reader 1
|
89.8 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Gadobutrol-enhanced CMRI-Reader 2
|
79.6 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Gadobutrol-enhanced CMRI-Reader 3
|
78.7 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Unenhanced CMRI-Reader 1
|
82.4 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Unenhanced CMRI-Reader 2
|
45.4 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment
Unenhanced CMRI-Reader 3
|
48.1 Sensitivity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=140 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment
|
74.3 Sensitivity %
Interval 66.2 to 81.3
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=108 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
|
89.8 Sensitivity %
Interval 82.5 to 94.8
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=50% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=234 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment
|
85.9 Specificity %
Interval 80.8 to 90.1
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=70% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=266 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment
|
85.0 Specificity %
Interval 80.1 to 89.0
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=50% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=141 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Gadobutrol-enhanced CMRI
|
74.3 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Unenhanced CMRI
|
46.4 Sensitivity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of \>=70% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=108 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Gadobutrolenhanced:True Positive(Sensitivity)
|
89.8 Sensitivity %
|
|
Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment
Unenhanced: True Positive (Sensitivity)
|
57.4 Sensitivity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery \[LAD\] / non-LAD / right coronary artery \[RCA\] / left circumflex artery \[LCX\]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of\>=50%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory(LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=103 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 1
|
43.8 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 2
|
31.3 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 3
|
34.4 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Investigator
|
45.3 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 1
|
84.5 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 2
|
68.9 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 3
|
71.8 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Investigator
|
76.7 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 1
|
85.5 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 2
|
69.7 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 3
|
69.7 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Investigator
|
71.1 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 1
|
69.4 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 2
|
48.6 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 3
|
47.2 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Investigator
|
55.6 Sensitivity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=87 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 1
|
70.6 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 2
|
52.9 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 3
|
56.9 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Investigator
|
68.6 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 1
|
90.8 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 2
|
78.2 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 3
|
80.5 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Investigator
|
88.5 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 1
|
90.3 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 2
|
80.6 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 3
|
82.3 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Investigator
|
83.9 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 1
|
77.1 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 2
|
50.0 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 3
|
50.0 Sensitivity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Investigator
|
70.8 Sensitivity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=138 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 1
|
92.8 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 2
|
97.1 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 3
|
93.5 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Investigator
|
91.2 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 1
|
91.9 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 2
|
97.7 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 3
|
96.5 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Investigator
|
95.3 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 1
|
82.3 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 2
|
91.1 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 3
|
87.9 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Investigator
|
87.7 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 1
|
88.9 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 2
|
94.4 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 3
|
95.4 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Investigator
|
93.5 Specificity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%), if \>=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of \>=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=190 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 1
|
90.0 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 2
|
95.3 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Reader 3
|
91.1 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LAD territory: Investigator
|
86.7 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 1
|
85.7 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 2
|
92.9 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Reader 3
|
91.8 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to non-LAD territory: Investigator
|
91.8 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 1
|
74.8 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 2
|
87.1 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Reader 3
|
85.0 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to RCA territory: Investigator
|
85.5 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 1
|
78.7 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 2
|
85.8 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Reader 3
|
87.2 Specificity %
|
|
Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments
Localization to LCX territory: Investigator
|
87.9 Specificity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR in the LMS.
Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=9 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Isolated, Reader 1
|
1 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Single-vessel, Reader 1
|
2 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
2-vessel, Reader 1
|
1 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
3-vessel, Reader 1
|
3 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Isolated, Reader 2
|
0 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Single-vessel, Reader 2
|
2 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
2-vessel, Reader 2
|
1 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
3-vessel, Reader 2
|
3 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Isolated, Reader 3
|
0 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Single-vessel, Reader 3
|
2 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
2-vessel, Reader 3
|
1 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
3-vessel, Reader 3
|
3 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Isolated, Investigator
|
0 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
Single-vessel, Investigator
|
2 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
2-vessel, Investigator
|
2 Participants
|
|
Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments
3-vessel, Investigator
|
3 Participants
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Sensitivity was calculated for detection of myocardial perfusion defects (MPD) on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=75 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Reader 1
|
56.1 Sensitivity %
Interval 42.4 to 69.3
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Reader 2
|
50.9 Sensitivity %
Interval 37.3 to 64.4
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Reader 3
|
49.1 Sensitivity %
Interval 35.6 to 62.7
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Investigator
|
57.1 Sensitivity %
Interval 43.2 to 70.3
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Reader 1
|
92.0 Sensitivity %
Interval 83.4 to 97.0
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Reader 2
|
76.0 Sensitivity %
Interval 64.7 to 85.1
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Reader 3
|
76.0 Sensitivity %
Interval 64.7 to 85.1
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Investigator
|
86.7 Sensitivity %
Interval 76.8 to 93.4
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=70% by QCA) as verified by SoR.
Sensitivity was calculated for detection of MPD on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If \>=1 myocardial region showed a myocardial perfusion defect with a RPS of \>=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=68 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Reader 1
|
85.3 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Reader 2
|
76.5 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Reader 3
|
76.5 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Single-vessel disease - Investigator
|
86.8 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Reader 1
|
97.5 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Reader 2
|
85.0 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Reader 3
|
82.5 Sensitivity %
|
|
Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments
Multi-vessel disease - Investigator
|
95.0 Sensitivity %
|
SECONDARY outcome
Timeframe: 0 to 30/40 min post-injectionPopulation: FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of \>=50% by QCA) as verified by SoR.
Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.
Outcome measures
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=376 Participants
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 1: Confident
|
74.7 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 1: Somewhat confident
|
15.7 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 1: Not confident
|
9.6 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 1: Missing
|
0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 2: Confident
|
86.4 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 2: Somewhat confident
|
12.8 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 2: Not confident
|
0.8 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 2: Missing
|
0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 3: Confident
|
63.0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 3: Somewhat confident
|
36.4 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 3: Not confident
|
0.5 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Reader 3: Missing
|
0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Investi.: Confident
|
91.2 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Investi.: Somewhat confident
|
8.2 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Investi.: Not confident
|
0.3 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Unenhanced/Investi.: Missing
|
0.3 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 1: Confident
|
88.3 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 1: Somewhat confident
|
8.2 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 1: Not confident
|
3.5 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 1: Missing
|
0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 2: Confident
|
75.5 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 2: Somewhat confident
|
23.4 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 2: Not confident
|
1.1 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 2: Missing
|
0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 3: Confident
|
74.7 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 3: Not confident
|
1.6 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 3: Missing
|
0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Investi.: Confident
|
79.0 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Investi.: Somewhat confident
|
19.1 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Investi.: Not confident
|
1.3 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Investi.: Missing
|
0.5 Percentage of Participants
|
|
Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments
Gadobutrol-enhanced/Reader 3: Somewhat confident
|
23.7 Percentage of Participants
|
Adverse Events
Gadobutrol 0.1 mmol/kg Body Weight
Serious adverse events
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=426 participants at risk
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
General disorders
Chest pain
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
Other adverse events
| Measure |
Gadobutrol 0.1 mmol/kg Body Weight
n=426 participants at risk
Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.2%
5/426 • Number of events 6 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Cardiac disorders
Bradycardia
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Cardiac disorders
Extrasystoles
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Cardiac disorders
Palpitations
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Gastrointestinal disorders
Nausea
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
General disorders
Chest discomfort
|
2.3%
10/426 • Number of events 11 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
General disorders
Chest pain
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
General disorders
Feeling hot
|
1.2%
5/426 • Number of events 5 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
General disorders
Pain
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Investigations
Blood pressure decreased
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Investigations
Oxygen saturation decreased
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Dizziness
|
0.70%
3/426 • Number of events 3 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Head discomfort
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Headache
|
1.9%
8/426 • Number of events 8 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Paraesthesia
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Presyncope
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Sciatica
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Nervous system disorders
Tremor
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Psychiatric disorders
Anxiety
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Psychiatric disorders
Panic reaction
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Psychiatric disorders
Sleep disorder
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
4/426 • Number of events 4 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Vascular disorders
Hypertension
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Vascular disorders
Hypertensive crisis
|
0.47%
2/426 • Number of events 2 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
|
Vascular disorders
Microangiopathy
|
0.23%
1/426 • Number of events 1 • From the time of gadobutrol injection until 24 ± 6 hours follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor is interested in the publication of the results of every study it performs. All relevant aspects regarding the publication will be part of the contract between the sponsor and the investigator/institution. The sponsor has made the information regarding the study protocol publicly available on the internet at www.clinicaltrials.gov.
- Publication restrictions are in place
Restriction type: OTHER