Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Coronary Microvascular Function and Fractional Flow Reserve in the Multicenter Registry
Not Applicable
Recruiting
- Conditions
- Coronary artery disease
- Registration Number
- JPRN-UMIN000051520
- Lead Sponsor
- Tokyo Medical University Hachioji Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1650
Inclusion Criteria
Not provided
Exclusion Criteria
1) Culprit lesions in patients with acute coronary syndrome 2) Graft lesions 3) Patients with congestive heart failure 4) Severe coronary stenosis lesions (>=90% stenosis by visual estimation) 5) Patients with a previous history of PCI and CABG (only INOCA arm) 6) Patients deemed inappropriate for inclusion by the principal investigators
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CAD arm: 1-year POCE (patient-oriented composite endpoints; a composite of all-cause death, any myocardial infarction, and any revascularization) INOCA arm: 1-year MACE (major adverse cardiovascular events; a composite of cardiac death, any myocardial infarction, any revascularization, hospitalization due to unstable angina)
- Secondary Outcome Measures
Name Time Method At enrollment 1) Normal values of CFR and IMR in each coronary artery (LAD, LCX, and RCA) 2) Relationship between FFR, angio-based FFR, and coronary microvascular function (CFR and IMR) 3) Frequency of discordant cases between RFR and coronary microvascular function (CFR and IMR) and their associated factors At 1-year follow-up 4) Improvement in clinical symptoms assessed by the Seattle Angina Questionnaire-7. 5) POCE 6) MACE 7) Heart failure requiring hospitalization 8) Stroke requiring hospitalization At 3-year follow-up 9) POCE 10) MACE 11) Heart failure requiring hospitalization 12) Stroke requiring hospitalization