Status:
COMPLETED
Regadenoson R-T Perfusion Imaging Trial
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Mayo Clinic
Astellas Pharma Inc
Conditions:
Coronary Artery Disease
Myocardial Perfusion Abnormalities
Eligibility:
All Genders
30+ years
Phase:
PHASE1
Brief 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...
Detailed Description
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD)...
Eligibility Criteria
Inclusion
- 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
- 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 \< 40%
- Large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation.
- Early positive treadmill EKG within the first stage of the test.
- History of \>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.
Key Trial Info
Start Date :
April 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00837369
Start Date
April 7 2009
End Date
December 1 2011
Last Update
December 27 2024
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Nebraska Medicial Center
Omaha, Nebraska, United States, 68105