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

• Conditions: Coronary Artery Disease

• Registration Number: NCT00894179
• Lead Sponsor: Henry Ford Health System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Status Verified: 2010-05
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-23
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Age > 18 years old
2. Able to provide consent
3. Scheduled for cardiac catheterization either with or without a prior functional stress imaging study

Exclusion Criteria

1. Any history of acute myocardial infarction, prior PCI in last 3 months, bypass surgery,
2. History of greater than first degree AV block, sick sinus syndrome in patients
3. Patients with a pacemaker/LBBB
4. History on uncontrolled arrhythmias
5. Patients with significant pulmonary disease, known or suspected bronchoconstrictive or bronchospastic lung disease or other hypersensitivity to adenosine
6. History of cardiac transplantation, hypertrophic cardiomyopathy, acute myocarditis or pericarditis, severe valvular heart disease
7. Hemodynamically unstable patients
8. 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
9. History of glaucoma or obstructive uropathy
10. Allergy or hypersensitivity to atropine
11. Participation in another investigational drug study within 1 month or participation in any previous regadenoson trial
12. Pregnancy, breast feeding, or not using an acceptable method of birth control (if premenopausal)
13. . History of end-stage renal disease on hemodialysis or peritoneal dialysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States