N/A
Completed N=140
Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging
Source: ClinicalTrials.gov NCT01021618 ↗Enrolled (actual)
140
Serious AEs
2.9%
Results posted
Dec 2012
Primary outcomePrimary: Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire — 11; 15 participants
Summary
Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected patients, protocols that combine exercise (either low-level or symptom-limited) with vasodilator stress agents have been found to be safe and effective in both identification of the presence and severity of CAD as well as risk stratification for adverse cardiac outcome. However, currently utilized combined stress protocols have drawbacks. Further refinement of combined stress protocols would potentially lead to more appropriate stress protocol selection for patients while enhancing laboratory efficiency. The purpose of this prospective, randomized study will be to evaluate the relative merits of combining regadenoson with symptom-limited exercise in patients clinically-referred for vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is a safe and feasible stress testing modality which is non-inferior to that which combines symptom-limited exercise with dipyridamole.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Adverse Events or Side Effects Graded "Severe" on Symptom Questionnaire |
11; 15 | — |
| SECONDARY Myocardial Perfusion Image Quality |
13; 33; 25; 55; 5; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise
- Age >=30 years
Exclusion Criteria
- Extremely limited functional capacity
- Age 200 mmHg systolic/>120 mmHg diastolic)
- Known hypertrophic cardiomyopathy with obstruction or severe aortic stenosis
- Decompensated congestive heart failure
- History of sick sinus syndrome or > first degree atrioventricular block in the absence of a functioning pacemaker
- Asthma or other bronchospastic reactive airway disease
- History of percutaneous coronary intervention or coronary artery bypass grafting, or documented history of acute myocardial infarction or unstable angina within one week of testing
- Patients at risk for hypotensive reaction to regadenoson
Data sourced from ClinicalTrials.gov (NCT01021618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.