Safety and Accuracy of Regadenoson-Atropine Stress Echocardiography in CAD (REGAT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: regadenoson and atropine

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

This will be a prospective study evaluating stable outpatients with no prior diagnosis of coronary disease who may or may not have had a prior functional stress imaging test and are going for a clinically indicated cardiac catheterization as deemed by their physician due to suspected coronary artery disease either based on symptoms or based on results for prior functional testing

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open label	Diagnostic test: regadenoson and atropine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease.	Patients undergoing REGAT (regadenoson +atropine) stress echocardiography were evaluated for wall motion abnormalities (ischemia) using REGAT stress echocardiography to predict > 70% luminal stenosis	within 7 days of the REGAT stress echocardiography
Sensitivity of Coronary Artery Territory	Sensitivity analysis of coronary artery territory using a 70% stenosis cutoff by angiography.	within 7 days of REGAT stress echocardiography
Specificity of Coronary Artery Territory	Specificity analysis on Coronary Artery Territory using a 70% stenosis cutoff by angiography.	within 7 days of REGAT stress echocardiography
Positive Predictive Value of Coronary Artery Territory	Analysis of positive predictive value of coronary artery territory using a 70% stenosis cutoff by angiography.	within 7 days of REGAT stress echocardiography
Negative Predictive Value of Coronary Artery Territory	Analysis of negative predictive value of coronary artery territory using a 70% stenosis cutoff by angiography.	within 7 days of REGAT stress echocardiography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Preferred the REGAT Stress Echocardiography Protocol Over Prior Stress Test	Patient post-procedure satisfaction survey administered immediately following the REGAT stress echocardiography protocol to assess tolerability and preference of REGAT stress echo protocol. The survey consisted of three questions in Likert format.	Following completion of REGAT stress echocardiography stress test

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Karthikeyan Ananthasubramaniam, MD FACC, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (Estimated): May 6, 2009

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; stress echocardiography; regadenoson; atropine; coronary angiogram
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: REGA-9B04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No