N/A
N=51
PCI Alternative Using Sustained Exercise
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT03520400 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Myocardial Perfusion Reserve — 2.76; 2.47; 2.82; 2.52 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Therapy (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Perfusion Reserve |
2.76; 2.47; 2.82; 2.52 | — |
| SECONDARY Peak VO2 |
20.21; 19.85; 22.4; 18.91 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03520400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.