PCI Alternative Using Sustained Exercise

NCT03520400 | Completed Results

• 1 other identifier: F7374-R
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease remains the leading cause of morbidity and mortality in the U.S. and is a major cause of disability in Veterans. Most of these deaths are due to coronary artery disease (CAD). The most common treatment for CAD is revascularization, an invasive procedure which usually involves placing a stent inside an artery that is diseased. However, exercise training is often overlooked because clinicians tend to focus on repairing the coronary circulation and the potential need for revascularization. Studies have shown that exercise training can be effective for patients with CAD and that it saves costs. In this study, invasive revascularization will be compared to a structured program of exercise training over one year. Comparisons will be made between groups for symptoms, coronary artery size and function using PET/CTA, and health care cost utilization.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Disease; Percutaneous Intervention; coronary artery disease; exercise therapy

Outcome Measures

Primary Outcomes (1)

• Myocardial Perfusion Reserve

  Measurement of myocardial blood flow has only been analyzed at baseline at this time. Intravenous 13NH3 will be used as the flow tracer and serial imaging with PET will be performed. Measurements will be performed at baseline, and after pharmacologic stress with dipyridamole. Myocardial blood flow at rest and following dipyridamole infusion will be expressed as ml flow/100 g/min. The myocardial perfusion reserve will be calculated as the ratio of the myocardial blood flow during stress (e.g. after dipyridamole) and the myocardial blood flow at rest. Commercially available software (Emory tool box) will be used to quantitatively analyze PET myocardial perfusion images.

  baseline and 1 year

Secondary Outcomes (1)

• Peak VO2

  baseline and after 1 year

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

Group receives one year of exercise and lifestyle intervention

Behavioral: Exercise Therapy

PCI group (usual care)

NO INTERVENTION

Group receives standard clinical care with no intervention

Interventions

Exercise Therapy BEHAVIORAL

Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.

Also known as: Exercise Training

Exercise Intervention Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable patients who have lesions appropriate for PCI based on American Heart Association/American College of Cardiology criteria will be considered for the study.
• Only patients with a good prognosis (annual mortality \<2% based on VA multivariate scores (57, 58) will be considered.

You may not qualify if:

• Patients with left main disease or proximal LAD disease, or:
• Unstable angina
• A history of left ventricular dysfunction (EF 30%)
• Pacemakers
• Atrial fibrillation
• Myocardial infarction within the last 3 months
• Diabetes
• Orthopedic problems interfering with the ability to exercise regularly

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Interventions

Exercise Therapy; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Jonathan Myers
• Organization: VA Palo Alto Health Care System

Drj993@aol.com

6504503440

Study Officials

• Jonathan N Myers, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: October 1, 2012
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 2, 2024
• Results First Posted: September 20, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data collected will be available for 5 years after completion of the study.
• Access Criteria: Following completion of the study in October 2018, the data will be available for 5 years.

Locations

US (1)