Trial Outcomes & Findings for Safety and Accuracy of Regadenoson-Atropine Stress Echocardiography in CAD (NCT NCT00894179)

Results Overview

Patients undergoing REGAT (regadenoson +atropine) stress echocardiography were evaluated for wall motion abnormalities (ischemia) using REGAT stress echocardiography to predict \> 70% luminal stenosis

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

within 7 days of the REGAT stress echocardiography

Results posted on

2026-05-22

Participant Flow

Between October 2009 and January 2012, out of 1596 outpatients referred for Coronary angiography we identified 54 patients meeting study criteria. Nine patients subsequently screen failed and hence we finally enrolled 45 patients into study.

The first 10 patients were part of the run-in phase to test the safety of the combination of regadenoson and atropine and the request of the Food and Drug Administration. The first 10 patients did go on to complete the entire protocol and are included in the total of 45 patients. The study was prematurely terminated due to slow enrollment and poor recruitment.

Participant milestones

Participant milestones
Measure	REGAT Group There is only one arm for this study. This was not a randomized or controlled trial. Only one group of patients underwent both REGAT protocol and coronary angiography.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Accuracy of Regadenoson-Atropine Stress Echocardiography in CAD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REGAT Group n=45 Participants Please note this study did not have different patient groups. This was not a randomized or controlled trial. There was only 1 group of patients who underwent both REGAT protocol and coronary angiography.
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=2 Participants
Age, Categorical >=65 years	14 Participants n=2 Participants
Age, Continuous	61 years STANDARD_DEVIATION 7 • n=2 Participants
Sex: Female, Male Female	19 Participants n=2 Participants
Sex: Female, Male Male	26 Participants n=2 Participants
Region of Enrollment United States	45 participants n=2 Participants

PRIMARY outcome

Timeframe: within 7 days of the REGAT stress echocardiography

Population: 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.

Patients undergoing REGAT (regadenoson +atropine) stress echocardiography were evaluated for wall motion abnormalities (ischemia) using REGAT stress echocardiography to predict \> 70% luminal stenosis

Outcome measures

Outcome measures
Measure	REGAT Group n=45 Participants There was only one group for this trial. This was not a randomized or controlled trial. This group of patients underwent both REGAT protocol and coronary angiography.
Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease. Overall significant stenosis in any epicardial coronary vessel	23 Participants
Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease. Significant Stenosis: Left Anterior Descending Artery	17 Participants
Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease. Significant Stenosis: Left Circumflex Artery	15 Participants
Number of Participants With REGAT Stress Echocardiography Protocol in the Detection of Significant Coronary Artery Disease. Significant Stenosis: Right Coronary Artery	12 Participants

PRIMARY outcome

Timeframe: within 7 days of REGAT stress echocardiography

Sensitivity analysis of coronary artery territory using a 70% stenosis cutoff by angiography.

Outcome measures

Outcome measures
Measure	REGAT Group n=45 Participants There was only one group for this trial. This was not a randomized or controlled trial. This group of patients underwent both REGAT protocol and coronary angiography.
Sensitivity of Coronary Artery Territory Left Circumflex Artery	6.7 percentage of stenosis Interval 2.0 to 30.0
Sensitivity of Coronary Artery Territory Right Coronary Artery	16.7 percentage of stenosis Interval 5.0 to 45.0
Sensitivity of Coronary Artery Territory Left Anterior Descending	58.8 percentage of stenosis Interval 38.0 to 80.0

PRIMARY outcome

Timeframe: within 7 days of REGAT stress echocardiography

Specificity analysis on Coronary Artery Territory using a 70% stenosis cutoff by angiography.

Outcome measures

Outcome measures
Measure	REGAT Group n=45 Participants There was only one group for this trial. This was not a randomized or controlled trial. This group of patients underwent both REGAT protocol and coronary angiography.
Specificity of Coronary Artery Territory Left Anterior Descending	92.9 percentage of stenosis Interval 77.0 to 98.0
Specificity of Coronary Artery Territory Left Circumflex Artery	93.3 percentage of stenosis Interval 79.0 to 98.0
Specificity of Coronary Artery Territory Right Coronary Artery	93.9 percentage of stenosis Interval 81.0 to 98.0

PRIMARY outcome

Timeframe: within 7 days of REGAT stress echocardiography

Analysis of positive predictive value of coronary artery territory using a 70% stenosis cutoff by angiography.

Outcome measures

Outcome measures
Measure	REGAT Group n=45 Participants There was only one group for this trial. This was not a randomized or controlled trial. This group of patients underwent both REGAT protocol and coronary angiography.
Positive Predictive Value of Coronary Artery Territory Left Anterior Descending	83.3 percentage of stenosis Interval 57.0 to 95.0
Positive Predictive Value of Coronary Artery Territory Left Circumflex Artery	33.3 percentage of stenosis Interval 7.0 to 80.0
Positive Predictive Value of Coronary Artery Territory Right Coronary Artery	50 percentage of stenosis Interval 15.0 to 85.0

PRIMARY outcome

Timeframe: within 7 days of REGAT stress echocardiography

Analysis of negative predictive value of coronary artery territory using a 70% stenosis cutoff by angiography.

Outcome measures

Outcome measures
Measure	REGAT Group n=45 Participants There was only one group for this trial. This was not a randomized or controlled trial. This group of patients underwent both REGAT protocol and coronary angiography.
Negative Predictive Value of Coronary Artery Territory Left Circumflex Artery	66.7 percentage of stenosis Interval 52.0 to 80.0
Negative Predictive Value of Coronary Artery Territory Left Anterior Descending	78.8 percentage of stenosis Interval 62.0 to 89.0
Negative Predictive Value of Coronary Artery Territory Right Coronary Artery	75.6 percentage of stenosis Interval 61.0 to 86.0

SECONDARY outcome

Timeframe: Following completion of REGAT stress echocardiography 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.

Outcome measures

Outcome measures
Measure	REGAT Group n=45 Participants There was only one group for this trial. This was not a randomized or controlled trial. This group of patients underwent both REGAT protocol and coronary angiography.
Number of Participants Who Preferred the REGAT Stress Echocardiography Protocol Over Prior Stress Test	37 Participants

Adverse Events

REGAT Patients

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	REGAT Patients n=45 participants at risk Please note this study did not have different patient groups. This was not a randomized or controlled trial. There was only 1 group of patients who underwent both REGAT protocol and coronary angiography.
Nervous system disorders Headache	44.4% 20/45 • Adverse Events collection occurred from consent to conclusion of post-monitoring period. A total time of 45 minutes.
Gastrointestinal disorders Dry mouth	60.0% 27/45 • Adverse Events collection occurred from consent to conclusion of post-monitoring period. A total time of 45 minutes.
Respiratory, thoracic and mediastinal disorders Dyspnea	60.0% 27/45 • Adverse Events collection occurred from consent to conclusion of post-monitoring period. A total time of 45 minutes.

Additional Information

K. Ananthasubramaniam

HenryfordHS

Phone: 3139162721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place