Trial Outcomes & Findings for Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation (NCT NCT01919450)

NCT ID: NCT01919450

Last Updated: 2018-08-16

Results Overview

The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 80 participants
• Primary outcome timeframe: 4 minutes
• Results posted on: 2018-08-16

Participant Flow

Subjects with a low pretest likelihood for CAD based on gender, symptoms and recent (<90 days) normal-clinically-indicated TMET, exercise echocardiogram or exercise myocardial perfusion SPECT test were recruited for consent and participation.

Participant milestones

Measure	10 Second Delay A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	2 Minute Delay A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	4 Minute Delay A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	1 Minute Delay A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Overall Study STARTED	20	20	20	20
Overall Study COMPLETED	20	20	20	19
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterization of Myocardial Blood Flow Measurements Using Lexiscan®™ (Regadenoson) (Lexiscan®™) Rubidium-82 Myocardial Perfusion PET: A Temporal-Dependency Investigation

Baseline characteristics by cohort

Measure	10 Second Delay n=20 Participants A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	2 Minute Delay n=20 Participants A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	4 Minute Delay n=20 Participants A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	1 Minute Delay n=20 Participants A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	Total n=80 Participants Total of all reporting groups
Age, Continuous	50.5 Years STANDARD_DEVIATION 13.8 • n=5 Participants	51.3 Years STANDARD_DEVIATION 10.4 • n=7 Participants	53.1 Years STANDARD_DEVIATION 9.6 • n=5 Participants	50.6 Years STANDARD_DEVIATION 9.9 • n=4 Participants	51.9 Years STANDARD_DEVIATION 11.0 • n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	45 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	20 participants n=4 Participants	80 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 minutes

The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

Outcome measures

Measure	4 Minute Delay n=18 Participants A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)	2.57 Ratio Standard Deviation 0.71

PRIMARY outcome

Timeframe: 2 mintues

The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

Outcome measures

Measure	4 Minute Delay n=19 Participants A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)	2.93 Ratio Standard Deviation 0.7

PRIMARY outcome

Timeframe: 10 seconds

The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

Outcome measures

Measure	4 Minute Delay n=19 Participants A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)	2.34 Ratio Standard Deviation .38

PRIMARY outcome

Timeframe: 1 minute

The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.

Outcome measures

Measure	4 Minute Delay n=18 Participants A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)	2.76 Ratio Standard Deviation .56

Adverse Events

10 Second Delay

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Minute Delay

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4 Minute Delay

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1 Minute Delay

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	10 Second Delay n=20 participants at risk A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	2 Minute Delay n=20 participants at risk A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	4 Minute Delay n=19 participants at risk A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.	1 Minute Delay n=20 participants at risk A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging. Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study. Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/20 • Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility. AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.	0.00% 0/20 • Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility. AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.	0.00% 0/19 • Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility. AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.	5.0% 1/20 • Number of events 1 • Adverse events were collected immediately post-informed consent and through the patient's entire visit to the imaging facility. AEs were recorded on an Adverse Event (AE) log. The AE log consisted of: 1.) Description of event; 2.) Start and stop time of event; 3.) Severity of event; 4.) Likelihood that the event was related to the study drug; 5.) Relationship of event to other test procedures; 6.) Any treatment actions taken, and 7.) the final outcome.

Other adverse events

Adverse event data not reported

Additional Information

Timothy M. Bateman, MD

Cardiovascular Imaging Technologies, LLC

Phone: 816-531-2842

Email: tbateman@cvit.com

Results disclosure agreements

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