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

NCT ID: NCT00894179

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Henry Ford Hospital

Principal Investigators

Karthikeyan Ananthasubramaniam, MD FACC

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karthikeyan Ananthasubramaniam, MD FACC

Role: CONTACT

kananth1@hfhs.org

313-916-2721

Dee Dee Wang, MD

Role: CONTACT

DWANG2@hfhs.org

313-916-2721

Facility Contacts

Karthikeyan Ananthasubramaniam, MD

Role: primary

kananth1@hfhs.org

313-916-2721

Dee Dee Wang, MD

Role: backup

DWANG2@hfhs.org

313-916-2721

Other Identifiers

REGA-9B04

Identifier Type: -

Identifier Source: org_study_id