Safety and Accuracy of Regadenoson-Atropine Stress Echocardiography in CAD

NCT00894179 | Terminated Results

• 1 other identifier: REGA-9B04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

coronary artery disease; stress echocardiography; regadenoson; atropine; coronary angiogram

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Number of Participants Who Preferred the REGAT Stress Echocardiography Protocol Over Prior Stress Test

  Following completion of REGAT stress echocardiography stress test

Study Arms (1)

Open label

OTHER

Diagnostic Test: regadenoson and atropine

Interventions

regadenoson and atropine DIAGNOSTIC_TEST

Open label

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Able to provide consent
• Scheduled for cardiac catheterization either with or without a prior functional stress imaging study

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The major limitations of our study was slow patient recruitment leading to premature termination of the study. Based on our observations of enrolled patients, we do not believe that additional recruitment would have changed the results/conclusions.

Results Point of Contact

• Title: K. Ananthasubramaniam
• Organization: HenryfordHS

kananth1@hfhs.org

3139162721

Study Officials

• Karthikeyan Ananthasubramaniam, MD FACC

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACC

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Locations

US (1)