Stable coronary artery disease
Conditions
Interventions
All patients attend outpatient cardiac rehabilitation (CR) after a cardiopulmonary exercise stress test. All patients will be required to participate in at least 36 sessions of outpatient cardiac reha
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing to provide written informed consent 2. Age 20 years or higher 3. Have angina symptoms with CCS classification I-III or asymptomatic myocardial ischemia 4. Have Significant myocardial ischemia on SPECT, PET, stress echocardiography, or stress perfusion MRI; or significant coronary artery stenosis (>90% stenosis or >50% stenosis with positive results in fractional flow reserve or resting indices) among major coronary arteries on invasive coronary angiography
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome, including unstable angina with CCS classification IV 2. Three-vessel coronary artery disease 3. Left main coronary artery disease 4. Myocardial infarction within 6 months 5. Coronary artery revascularization within 6 months 6. Contraindication to antiplatelets 7. Left bundle branch block or Wolff-Parkinson-White syndrome 8. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of heart failure within 6 months 9. Left ventricular ejection fraction < 35% 10. Pulmonary hypertension requiring drug therapy 11. Moderate or severe valvular heart disease or previous surgical/percutaneous treatment for valvular heart disease 12. Dilated or hypertrophic cardiomyopathy 13. Moderate or severe aortic aneurysm 14. Cardiac implantable electronic device including pacemaker, implantable cardioverter defibrillator, or biventricular pacemaker implantation 15. Left or right ventricular assist device or heart transplantation 16. Unable to exercise due to musculoskeletal disease or peripheral arterial disease 17. Terminal illness 18. Pregnant or lactating women 19. Estimated glomerular filtration rate <30 mL/min/1.73 m2, maintenance dialysis, peritoneal dialysis, or post-renal transplantation 20. Severe dementia 21. Home is far away from an outpatient cardiac rehabilitation center 22. Participating in another clinical trial involving interventions 23. Treating physician judged it inappropriate to participate in the study 24. Do not understand the Japanese language 25. Study researchers and their family members
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaire (SAQ)-7 summary score at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Following outcomes at 6 months 1. Subscores of the three items of the Seattle Angina Questionnaire (SAQ)-7 (physical limitation, angina frequency, quality of life) 2. Summary score of the SF-12 (Physical component summary [PCS], Mental component summary [MCS], Role/Social component summary [RCS]) and sub-scores (Physical functioning [PF], Role physical [RP], Bodily pain [BP], General health [GH], Vitality [VT], Social functioning [SF], Role emotional [ RE], Mental health [MH]) 3. Summary score of Hospital and Anxiety Depression Scale (HADS) (HADS-Depression [D], HADS-Anxiety [D]) 4. Composite outcome of all-cause mortality and myocardial infarction 5. all-cause mortality 6. Cardiac death 7. Myocardial infarction 8. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) 9. Hospitalization for heart failure 10. Exercise capacity (Peak VO2, anaerobic threshold [AT], peak work rate [WR], exercise time to >1 mm ST depression) | — |
Countries
Japan
Contacts
Public ContactTomotsugu Seki
Kyoto Prefectural University of Medicine Department of Cardiovascular Medicine, Graduate School of Medical Science,
Outcome results
None listed