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Arm Exercise Versus Pharmacologic Stress Testing for Clinical Outcome

NCT03449888 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 133

Last updated 2022-02-17

No results posted yet for this study

Summary

This is a 5-year clinical trial to evaluate whether arm exercise electrocardiographic (ECG) stress testing without or with coronary artery calcium scoring (-/+ CAC) is non-inferior to treadmill ECG stress testing -/+ CAC and pharmacologic myocardial perfusion imaging as an initial evaluation to detect obstructive coronary artery disease, determined by cardiac computed tomographic angiography (CTA) and to predict clinical outcome, defined by a primary clinical endpoint of the composite of cardiovascular (CV) mortality, myocardial infarction, and 90-day post-stress test coronary artery revascularization and secondary clinical endpoints of all-cause mortality and CV mortality.

Conditions

  • Veterans Referred to the St. Louis VAMC Stress Tes

Interventions

PROCEDURE

Regadenoson myocardial perfusion imaging stress test

Best fit model of pharmacologic myocardial perfusion imaging data, including summed stress and difference scores, gated left ventricular ejection fraction, transient ischemic dilatation, and heart rate response to regadenoson data.

PROCEDURE

Arm exercise electrocardiographic stress test

Published arm exercise score and best fit model of arm exercise ECG stress testing data.

PROCEDURE

Treadmill electrocardiographic stress test

Duke Treadmill Score and best fit model of treadmill exercise ECG stress testing data.

PROCEDURE

Coronary artery calcium score and cardiac computed tomographic angiography

Coronary artery calcium score by Agatston criteria and severe obstructive coronary artery disease \> 70% by cardiac computed tomographic angiography or invasive coronary arteriography.

Sponsors & Collaborators

  • VA St. Louis Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Wade H. Martin, MD · St. Louis VA Medical Center John Cochran Division, St. Louis, MO

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-02-05
Completion
2021-02-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449888 on ClinicalTrials.gov