Phase 1
N=100
Regadenoson R-T Perfusion Imaging Trial
Coronary Artery Disease · Myocardial Perfusion Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT00837369 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress — 98; 98 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Regadenoson (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress |
98; 98 | <0.001 sig |
Summary
To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.
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 and coronary angiography
- Have at least an intermediate likelihood of coronary disease based on the following clinical profile
- 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., New York Heart Association (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 atrioventricular (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.
Data sourced from ClinicalTrials.gov (NCT00837369). 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.