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

Coronary Artery Disease Clinical Trial

— REGAT  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00894179
• Other study ID #: REGA-9B04
• Status: Unknown status
• Phase: N/A
• First received: May 4, 2009
• Last updated: June 21, 2011
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2010
• Source: Henry Ford Health System
• Contact: Karthikeyan Ananthasubramaniam, MD FACC
• Phone: 313-916-2721
• Email: kananth1[@]hfhs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 110
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the safety and tolerability (using patient questionnaire) of REGAT stress echocardiography		1-7 days after stress test
Secondary	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