Coronary Artery DiseaseREGATNCT00894179

Safety and Accuracy of Regadenoson-Atropine Stress Echocardiography in CAD

A study testing regadenoson and atropine in people with Coronary Artery Disease, run by Henry Ford Health System at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: regadenoson and atropine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Apr 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Henry Ford Hospital
Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: 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.

Conditions: Coronary Artery Disease
Being tested: regadenoson and atropine
Keywords: coronary artery disease, stress echocardiography, regadenoson, atropine, coronary angiogram
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

regadenoson and atropineDiagnostic test

Study groups in NCT00894179
Study group	Role	What they receive
Open label	Other	Not described Receives: Diagnostic Test: regadenoson and atropine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 7 days of REGAT stress echocardiography

Secondary outcomes (1)

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.
Measured: Following completion of REGAT stress echocardiography stress test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Apr 2012

First posted6 May 2009 (estimated)
Study startOct 2009
Primary completionApr 2012
Study completionApr 2012

Why it stopped: Slow recruitment and interim analysis results

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00894179
Sponsor's protocol ID: REGA-9B04
Acronym: REGAT
Status last verified: Apr 2026
First submitted: 4 May 2009
Last updated: 22 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility, Safety and Accuracy of Regadenoson-Atropine (REGAT) Stress Echocardiography for Diagnosis of Coronary Artery Disease: Angiographic Correlative Study
ClinicalTrials.gov ID: NCT00894179
Acronym / sponsor ID: REGAT / REGA-9B04
Conditions: Coronary Artery Disease
Keywords: coronary artery disease, stress echocardiography, regadenoson, atropine, coronary angiogram
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment and interim analysis results
Enrolment: 45 participants (actual)
Lead sponsor: Henry Ford Health SystemUniversity, hospital or other
Study start: Oct 2009 (actual)
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 6 May 2009 (estimated)
Results: Posted 22 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label	Other	Diagnostic Test: regadenoson and atropine

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
regadenoson and atropine	Diagnostic test	Open label

Primary outcome

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

1 secondary outcome

Number of Participants Who Preferred the REGAT Stress Echocardiography Protocol Over Prior Stress Test
Time frame: Following completion of REGAT stress echocardiography stress test

Results and safety

Results posted to the registry on 22 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
REGAT Group	45	45

Primary outcome: Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease.

Time frame: within 7 days of the REGAT stress echocardiography. Count of participants. Unit: Participants

Measure	REGAT Patients n = 45
Overall significant stenosis in any epicardial coronary vessel	23
Significant Stenosis: Left Anterior Descending Artery	17
Significant Stenosis: Left Circumflex Artery	15
Significant Stenosis: Right Coronary Artery	12

REGAT Patients: p <0.05, Spearman correlation coefficients

Population analysed: This study was prospectively designed for 110 patients. The study terminated prematurely at 45 patients due to very slow recruitment and interim results showing no reason to continue further with the study.

Primary outcome: Sensitivity of Coronary Artery Territory

Time frame: within 7 days of REGAT stress echocardiography. Mean (95% Confidence Interval). Unit: percentage of stenosis

Measure	REGAT Group n = 45
Left Anterior Descending	58.8 (38 to 80)
Left Circumflex Artery	6.7 (2 to 30)
Right Coronary Artery	16.7 (5 to 45)

Primary outcome: Specificity of Coronary Artery Territory

Time frame: within 7 days of REGAT stress echocardiography. Mean (95% Confidence Interval). Unit: percentage of stenosis

Measure	REGAT Group n = 45
Left Anterior Descending	92.9 (77 to 98)
Left Circumflex Artery	93.3 (79 to 98)
Right Coronary Artery	93.9 (81 to 98)

Primary outcome: Positive Predictive Value of Coronary Artery Territory

Time frame: within 7 days of REGAT stress echocardiography. Mean (95% Confidence Interval). Unit: percentage of stenosis

Measure	REGAT Group n = 45
Left Anterior Descending	83.3 (57 to 95)
Left Circumflex Artery	33.3 (7 to 80)
Right Coronary Artery	50 (15 to 85)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events collection occurred from consent to conclusion of post-monitoring period. A total time of 45 minutes.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
REGAT Patients	0 of 45 (0%)	45 of 45 (100%)	0 of 45

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karthikeyan Ananthasubramaniam, MD FACC principal investigator

Henry Ford Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing regadenoson and atropine in people with Coronary Artery Disease, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease. (time frame: within 7 days of the REGAT stress echocardiography). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00894179.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.