Arm Exercise Versus Pharmacologic Stress Testing for Clinical Outcome

NCT03449888 | Terminated DMC

• 2 other identifiers: CARA-008-17F1 101 CX001345-01A3
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite of cardiovascular mortality, myocardial infarction, and 90-day post-stress test coronary artery revascularization

  Death from a cardiovascular cause, occurrence of myocardial infarction, and 90-day post-stress test coronary artery revascularization by any technique determined from VA, National Death Index, Missouri Health and Human Services, and non-VA medical records, and patient follow-up information.

  5 years

Secondary Outcomes (2)

• All-cause mortality

  5 years

• Cardiovascular mortality

  5 years

Other Outcomes (1)

• Obstructive coronary artery disease

  5 years

Study Arms (1)

St. Louis VA Healthcare System stress testing referrals

St. Louis VA Healthcare System cardiac stress testing laboratory referrals who are eligible and willing to complete an arm exercise ECG stress test, a treadmill ECG stress test if able, a regadenoson myocardial perfusion imaging stress test, and a coronary artery calcium score and cardiac computed tomographic angiography evaluation within 60 days if not referred for invasive coronary arteriography.

Procedure: Regadenoson myocardial perfusion imaging stress test; Procedure: Arm exercise electrocardiographic stress test; Procedure: Treadmill electrocardiographic stress test; Procedure: Coronary artery calcium score and cardiac computed tomographic angiography

Interventions

Regadenoson myocardial perfusion imaging stress test PROCEDURE

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.

Also known as: Lexiscan

St. Louis VA Healthcare System stress testing referrals

Arm exercise electrocardiographic stress test PROCEDURE

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

Also known as: Arm exercise ECG

St. Louis VA Healthcare System stress testing referrals

Treadmill electrocardiographic stress test PROCEDURE

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

Also known as: Treadmill ECG

St. Louis VA Healthcare System stress testing referrals

Coronary artery calcium score and cardiac computed tomographic angiography PROCEDURE

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

Also known as: Coronary calcium score and cardiac CTA

St. Louis VA Healthcare System stress testing referrals

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any veteran referred to the St. Louis VA Healthcare System stress testing laboratory

You may qualify if:

• Any veteran referred to the St. Louis VA Healthcare System stress testing laboratory for a cardiac stress test

You may not qualify if:

• Contra-indications to stress testing such as acute coronary syndrome, uncompensated heart failure, or unstable cardiac dysrhythmias Inability to perform arm exercise stress testing
• Contra-indications to regadenoson stress testing such as significant reversible airway disease, heart block, or low blood pressure
• An abnormal baseline ECG (e.g. left bundle branch block, widespread ST segment depression of at least 1 mm, ventricular paced rhythm) that precludes interpretation of the stress ECG
• Contra-indications to cardiac computed tomographic angiography (CTA) such as contrast allergies and renal dysfunction (glomerular filtration rate \< 30 ml/min)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA St. Louis Health Care System: collaborator

Study Sites (1)

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

MeSH Terms

Interventions

regadenoson

Study Officials

• Wade H. Martin, MD

  St. Louis VA Medical Center John Cochran Division, St. Louis, MO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: July 1, 2018
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available indefinitely after completion of the study 6/30/2023
• Access Criteria: Data will be made available to outside investigators for purposes approved by the Principal Investigator, Co-investigators and St. Louis VA Healthcare System Institutional Review Board

Locations

US (1)