Regadenoson Real Time Perfusion Imaging Trial-Optison (NCT01489176) | Clinical Trial Compass
CompletedPhase 3
Regadenoson Real Time Perfusion Imaging Trial-Optison
United States50 participantsStarted 2012-07-31
Plain-language 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.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 40%
* Large inducible perfusion defects or wall moti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.