Mode
Text Size
Log in / Sign up
Phase 1 N=100 Diagnostic

Regadenoson R-T Perfusion Imaging Trial

Coronary Artery Disease · Myocardial Perfusion Abnormalities

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search