Phase 3
Completed N=50
Regadenoson Real Time Perfusion Imaging Trial-Optison
Coronary Artery Disease · Myocardial Perfusion Abnormalities
Source: ClinicalTrials.gov NCT01489176 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Number of Participants With Coronary Stenosis — 50 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose if this study is to examine how effective Regadenoson is in detecting coronary artery disease during a stress echocardiogram when Optison is administered. Optison is a contrast agent that improves the images of the heart on the echocardiogram (echo) machine. Optison is approved by the Food and Drug Administration (FDA) to use during stress echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is used to chemically increase the heart rate and is approved for nuclear imaging tests. Regadenoson is a FDA approved drug but not for the intended use in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Coronary Stenosis |
50 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female. Age ≥ 30 years.
- Resting Left Ventricular Ejection Fraction > 40% using Simpson's biplane measurement.
- Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
- Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization.
- Be conscious and coherent, and able to communicate effectively with trial personnel.
- Agreeable to undergo the additional stress test (which is being performed for research purposes only, not for clinical care) and coronary angiography (which is being performed for clinical care) based on the following clinical profile: Have at least an intermediate likelihood of coronary disease based.
- Good apical echo images with at least 50% of each coronary artery territory well visualized.
Exclusion Criteria
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Pregnancy or lactation.
- Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
- Life expectancy of less than two months or terminally ill.
- Congestive (idiopathic) or hypertrophic cardiomyopathy.
- Known left main disease.
- Heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis.
- Resting Left Ventricular Ejection Fraction 1st degree heart block, sick sinus syndrome or high grade AV block without a pacemaker.
- Dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours.
- Participation in another investigational study within one month of this study.
- Anyone in whom a stress test should not be performed prior to cardiac catheterization.
Data sourced from ClinicalTrials.gov (NCT01489176). 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.