Regadenoson Real Time Perfusion Imaging Trial-Optison
Condition: Coronary Artery Disease; Myocardial Perfusion Abnormalities
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Regadenoson; Optison
Intervention description: A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Intervention MeSH terms: Regadenoson
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Stress Echocardiography; Real-Time Perfusion Imaging; Regadenoson; Optison

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.
    

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 (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 motion abnormalities during prior stress
             imaging study associated with left ventricular cavity dilatation.

          -  Early positive treadmill ECG within the first stage of the test.

          -  History of > 1st degree heart block, sick sinus syndrome or high grade 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.

          -  Anyone in whom a stress test should not be performed prior to cardiac catheterization.