Status:
UNKNOWN
Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease
Lead Sponsor:
Henry Ford Health System
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
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 a...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Able to provide consent
- Scheduled for cardiac catheterization either with or without a prior functional stress imaging study
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00894179
Start Date
May 1 2009
End Date
December 1 2011
Last Update
June 23 2011
Active Locations (1)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202