Safety and Accuracy Study of Regadenoson Atropine Combination for Stress Echocardiography in Identification of Coronary Artery Disease (REGAT)
Recruitment status was: Recruiting
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.
Coronary Artery Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Feasibility, Safety and Accuracy of Regadenoson-Atropine ( REGAT) Stress Echocardiography for the Diagnosis of Coronary Artery Disease: An Angiographic Correlative Study|
- 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.
- Evaluate the safety and tolerability (using patient questionnaire) of REGAT stress echocardiography [ Time Frame: 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
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2011|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894179
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Karthikeyan Ananthasubramaniam, MD FACC||Henry Ford Hospital|