Trial Outcomes & Findings for Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging (NCT NCT01021618)

Last Updated: 2013-03-21

Results Overview

Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as "severe" by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

24 hours

Results posted on

2013-03-21

Participant Flow

Recruitment took place in the Hartford Hospital Nuclear Cardiology Laboratory from January 2010 and February 2012.

At the onset of the study, only subjects with scores greater than or equal to 9.95 were randomized. After the first 96 patients had been screened and 55 randomized with no adverse events in the study group, this restriction was removed.

Participant milestones

Participant milestones
Measure	Vasodilator-exercise Stress Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.	Exercise-vasodilator Stress Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
Overall Study STARTED	44	96
Overall Study COMPLETED	44	96
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vasodilator-exercise Stress n=44 Participants Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.	Exercise-vasodilator Stress n=96 Participants Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint	Total n=140 Participants Total of all reporting groups
Age Continuous	59 years STANDARD_DEVIATION 13 • n=5 Participants	63 years STANDARD_DEVIATION 11 • n=7 Participants	62 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	44 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	52 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	21 Participants n=5 Participants	50 Participants n=7 Participants	71 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	13 Participants n=5 Participants	24 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Black	8 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Known Coronary Artery Disease Any known coronary disease	15 participants n=5 Participants	29 participants n=7 Participants	44 participants n=5 Participants
Known Coronary Artery Disease No known coronary disease	29 participants n=5 Participants	67 participants n=7 Participants	96 participants n=5 Participants
Indication for Stress Testing Chest Pain	36 participants n=5 Participants	71 participants n=7 Participants	107 participants n=5 Participants
Indication for Stress Testing Dyspnea	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Indication for Stress Testing Arrhythmia	1 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants
Indication for Stress Testing Syncope or Near-Syncope	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Indication for Stress Testing Other	1 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.

Outcome measures

Outcome measures
Measure	Vasodilator-exercise Stress n=44 Participants Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.	Exercise-vasodilator Stress n=94 Participants Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire	11 participants	15 participants

SECONDARY outcome

Timeframe: 0 hours

Population: Note that images were unavailable in one vasodilator-exercise patient because of urgent catheterization after stress test without imaging and one exercise-vasodilator patient for technical reasons.

Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).

Outcome measures

Outcome measures
Measure	Vasodilator-exercise Stress n=43 Participants Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.	Exercise-vasodilator Stress n=95 Participants Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
Myocardial Perfusion Image Quality Excellent	13 participants	33 participants
Myocardial Perfusion Image Quality Good	25 participants	55 participants
Myocardial Perfusion Image Quality Fair	5 participants	7 participants
Myocardial Perfusion Image Quality Poor	0 participants	0 participants

Adverse Events

Vasodilator-exercise Stress

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Exercise-vasodilator Stress

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vasodilator-exercise Stress n=44 participants at risk Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.	Exercise-vasodilator Stress n=94 participants at risk；n=96 participants at risk Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.3% 1/44 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	1.0% 1/96 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
General disorders Hypotension	2.3% 1/44 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	0.00% 0/96 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/44 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	1.0% 1/96 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.

Other adverse events

Other adverse events
Measure	Vasodilator-exercise Stress n=44 participants at risk Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.	Exercise-vasodilator Stress n=94 participants at risk；n=96 participants at risk Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
General disorders Severe Flushing	4.5% 2/44 • Number of events 2 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	1.1% 1/94 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Respiratory, thoracic and mediastinal disorders Severe Shortness of Breath	15.9% 7/44 • Number of events 7 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	13.8% 13/94 • Number of events 13 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Nervous system disorders Severe Headache	6.8% 3/44 • Number of events 3 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	0.00% 0/94 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Respiratory, thoracic and mediastinal disorders Severe Chest Discomfort	15.9% 7/44 • Number of events 7 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	2.1% 2/94 • Number of events 2 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Nervous system disorders Severe Dizziness	9.1% 4/44 • Number of events 4 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	2.1% 2/94 • Number of events 2 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Gastrointestinal disorders Severe Nausea	0.00% 0/44 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	1.1% 1/94 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.
Gastrointestinal disorders Severe Abdominal Pain	2.3% 1/44 • Number of events 1 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.	2.1% 2/94 • Number of events 2 Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and were excluded from the "other adverse events" analysis.

Additional Information

Gary V Heller, MD, PhD

Hartford Hospital

Phone: 860-545-5527

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place