Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Coronary Microvascular Function and Fractional Flow Reserve in the Multicenter Registry

Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Coronary Microvascular Function and Fractional Flow Reserve in the Multicenter Registry - J-ADVANCE Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051520

Enrollment

1650

Registered

2023-07-17

Start date

2023-07-18

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

Coronary artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients willing to provide written informed consent 2) Patients over 20 years old 3) Patients undergoing coronary angiography due to clinically suspected coronary artery disease 4) Patients performing FFR and microvascular function (CFR and IMR) measurement with >=50% stenosis by visual estimation on coronary angiography (CAD arm) 5) Patients performing ACH provocation test and FFR and microvascular function (CFR and IMR) measurement with <50% stenosis by visual estimation on coronary angiography (INOCA arm)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactShoichi Kuramitsu

Sapporo Cardio Vascular Clinic Cardiovascular Medicine

kuramitsu@heart-kizuna.com0117847847

Outcome results