Cardiac Rehabilitation for Patients With Stable Ischemic Heart Disease Without Revascularization　- Rationale and...

Area of Science:

• Cardiology
• Rehabilitation Medicine
• Clinical Trials

Background:

• Optimal medical therapy (OMT) is recommended for stable ischemic heart disease (SIHD).
• The role of cardiac rehabilitation (CR) in SIHD patients without revascularization requires further investigation.
• Efficacy and safety of CR in this specific patient population remain unclear.

Purpose of the Study:

• To evaluate the efficacy and safety of CR in Japanese patients with SIHD without revascularization.
• To assess the impact of CR on health-related quality of life (HRQL) and exercise capacity.
• To provide data for future randomized controlled trials.

Main Methods:

• Prospective, single-arm, open-label pilot study (Pre-START).
• Inclusion of Japanese patients with SIHD without revascularization.
• Guideline-based OMT plus 36 outpatient CR sessions within 5 months.
• Primary endpoint: change in Seattle Angina Questionnaire-7 summary score at 6 months.

Main Results:

• The study aims to determine clinically important changes (≥5 points) in HRQL.
• Secondary endpoints include changes in other HRQL measures and exercise capacity.
• Clinical outcomes between enrollment and 6-month follow-up will be assessed.

Conclusions:

• The Pre-START study is expected to provide valuable evidence on CR efficacy and safety in SIHD patients.
• Findings will inform the design of subsequent randomized controlled trials.
• The study contributes essential data for optimizing SIHD management strategies.