Regadenoson R-T Perfusion Imaging Trial

Study Overview
=================
Brief Summary
-----------------
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the A2A Receptor agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in diameter by quantitive angiography will be analyzed

Official Title
-----------------
Regadenoson Real Time Perfusion Imaging Trial

Conditions
-----------------
Coronary Artery Disease, Myocardial Perfusion Abnormalities

Intervention / Treatment
-----------------
* Drug: Regadenoson


Participation Criteria
=================
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., 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement. | Drug: Regadenoson<br>* 400ug IV bolus injection, single dosage<br>* Other names: Lipid encapsulated microbubbles;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| more feasible and accurate way to detect significant coronary artery disease |  | upon completion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress echocardiography, SPECT, Myocardial perfusion imaging