Regadenoson Real Time Perfusion Imaging Trial-Optison

Stress perfusion imaging has primarily been done with radionuclide scintigraphy or single
photon emission computed tomography (SPECT) and has not reached its full clinical potential
because of the poor spatial resolution of SPECT, increased expense of this procedure,
patient exposure to ionizing radiation, and lack of availability. The A2A receptor agonist
Regadenoson has been utilized to detect myocardial perfusion abnormalities during SPECT
myocardial perfusion imaging.

A 100 patient pilot study (Regadenoson Real Time Perfusion Imaging Trial, IRB #566-08-FB)
demonstrated the feasibility and accuracy of real-time perfusion echocardiography (RTPE) in
detecting coronary artery disease following Regadenoson bolus injection and Definity as an
ultrasound contrast agent. The aim of this study is to determine whether similar feasibility
and accuracy can be achieved with Optison (a Food and Drug Administration approved
ultrasound contrast agent that differs slightly in microbubble size and composition) in
detecting coronary artery disease (CAD) following Regadenoson bolus injection. As with the
original study, sensitivity, specificity, and accuracy of perfusion and wall motion analysis
to identify a coronary stenosis >50% in diameter by quantitative angiography will be
analyzed.

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.