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N/A N=51 Randomized Prevention

PCI Alternative Using Sustained Exercise

Cardiovascular Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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