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 range30 Years
SexALL
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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…