Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease

Study Overview
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Brief Summary
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Purpose: The investigators plan to test a newly FDA approved pharmacologic stress agent, Regadenoson, in conjunction with atropine in the use of stress echocardiography for the diagnosis of coronary artery disease. The selective nature of Regadenoson allows for its use in patients with contraindications to the currently used drug, Adenosine, which is non-selective. Furthermore, the proposed protocol can be completed faster and without radiation exposure than the current protocol with adenosine. Design: This is a prospective study evaluating people with no prior diagnosis of coronary disease with a prior stress test and are scheduled for cardiac catheterization. Patients who meet inclusion criteria will undergo regadenoson-atropine echocardiography protocol prior to their catheterization. The study will be interpreted by two independent readers blinded to the catheterization results. The sensitivity, specificity, positive and negative predictive values of the regadenoson-atropine study will be then be calculated using the coronary angiogram as a gold standard.

Official Title
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Feasibility, Safety and Accuracy of Regadenoson-Atropine ( REGAT) Stress Echocardiography for the Diagnosis of Coronary Artery Disease: An Angiographic Correlative Study

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Able to provide consent Scheduled for cardiac catheterization either with or without a prior functional stress imaging study Exclusion Criteria: Any history of acute myocardial infarction, prior PCI in last 3 months, bypass surgery, History of greater than first degree AV block, sick sinus syndrome in patients Patients with a pacemaker/LBBB History on uncontrolled arrhythmias Patients with significant pulmonary disease, known or suspected bronchoconstrictive or bronchospastic lung disease or other hypersensitivity to adenosine History of cardiac transplantation, hypertrophic cardiomyopathy, acute myocarditis or pericarditis, severe valvular heart disease Hemodynamically unstable patients Dipyridamole use within 30 hours, consumption of methylxanthines (e.g., tea, coffee, caffeinated soft drinks, chocolate, or cocoa) within 12 hours, or use of sublingual nitroglycerin within 2 hours History of glaucoma or obstructive uropathy Allergy or hypersensitivity to atropine Participation in another investigational drug study within 1 month or participation in any previous regadenoson trial Pregnancy, breast feeding, or not using an acceptable method of birth control (if premenopausal) . History of end-stage renal disease on hemodialysis or peritoneal dialysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensitivity, specificity, positive and negative predictive value and accuracy of REGAT stress echocardiography protocol in the detection of coronary artery disease, using > 70% luminal stenosis on coronary angiogram as gold standard. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability (using patient questionnaire) of REGAT stress echocardiography |  | 1-7 days after stress test | 
| Compare sensitivity, specificity, positive and negative predicative value and accuracy of a REGAT stress echocardiography protocol to other stress imaging modalities used in the patient cohort as per design of study |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, stress echocardiography, regadenoson, atropine, coronary angiogram