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Cardiac Rehabilitation for Patients with Stable Angina after PCI: The START Study

Stable Angina Rehabilitation Trial (START): A Multicenter, Randomized, Wait-list Controlled Trial of Cardiac Rehabilitation following Percutaneous Coronary Intervention - START

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1050250012
Enrollment
500
Registered
2025-05-02
Start date
2025-05-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Coronary Artery Disease Stable coronary artery disease, Angina perctoris, Ischemic heart disease, Chronic coronary syndrome, Chronic coronary disease, Percutaneous coronary intervention

Interventions

In the intervention group, supervised outpatient exercise therapy (cardiac rehabilitation) will be initiated within one month after percutaneous coronary intervention for stable coronary artery diseas
Cardiac Rehabilitation
Cardiac rehabilitation, Supervised exercise training, Secondary prevention

Sponsors

Seki Tomotsugu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with stable coronary artery disease who have undergone percutaneous coronary intervention within the past month 2. A summary score of 90 or less on the Seattle Angina Questionnaire-7 (SAQ-7) at enrollment 3. Aged 18 years or older 4. Capable of providing written informed consent

Exclusion criteria

Exclusion criteria: 1. History of acute coronary syndrome, including unstable angina or myocardial infarction within the past 6 months 2. Symptomatic heart failure (NYHA class II or higher), or hospitalization for heart failure within the past 6 months 3. Left ventricular ejection fraction less than 35% 4. Moderate to severe valvular heart disease, or history of surgical or catheter-based intervention for valvular disease within the past 6 months 5. Dilated or hypertrophic cardiomyopathy 6. Moderate to severe aortic or peripheral arterial disease 7. History of heart transplantation or implantation of a ventricular assist device 8. Diseases that significantly limit exercise capacity, including cerebrovascular, respiratory, musculoskeletal, or peripheral arterial diseases 9. Terminal illness or limited life expectancy due to other physical conditions 10. Pregnant or breastfeeding women 11. Estimated glomerular filtration rate <30 mL/min/1.73 m2, on maintenance dialysis or peritoneal dialysis, or post-kidney transplantation 12. Dementia or severe cognitive impairment 13. Inability to regularly attend outpatient cardiac rehabilitation 14. Any other condition deemed by the investigators to make the patient unsuitable for participation

Design outcomes

Primary

MeasureTime frame
Summary Score of the Seattle Angina Questionnaire-7 (SAQ-7) at 6 months

Secondary

MeasureTime frame
1. Subscales of the Seattle Angina Questionnaire-7 (SAQ-7) 2. Summary and subscales of the 12-Item Short Form Health Survey (SF-12) 3. EQ-5D score 4. Exercise capacity measured by cardiopulmonary exercise testing (CPET), including peak oxygen uptake (peak VO2) and anaerobic threshold 5. Cardiovascular events, including all-cause death, cardiovascular death, myocardial infarction, revascularization, hospitalization for heart failure, and stroke 6. Medical costs

Contacts

Public ContactTomotsugu Seki

Kyoto Prefectural University of Medicine

tseki@koto.kpu-m.ac.jp+81-75-251-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026