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Active, not recruiting Observational

Multicenter Registry of Coronary Flow-Derived Indexes for Coronary Microvascular Disease (Multicenter FLOW-CMD Registry)

NCT05369182 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-04-22
Last updated
2026-02-12

Condition(s) studied

Coronary Microvascular DiseaseCoronary Artery DiseaseIschemic Heart Disease

Investigational drug(s) / intervention(s)

Invasive physiologic assessmentIntravascular imaging

Invasive physiologic assessment: All coronary physiologic parameters are measured following diagnostic angiography. Resting pd/pa, FFR, CFR and IMR will be calculated using coronary physiologic parameters. In patients treated by PCI, post-PCI physiologic assessment including CFR, IMR, and FFR will be performed.

Intravascular imaging: By the operator's discretion, stent-optimization will be performed under intravascular imaging devices (IVUS \[Boston Scientific, Natick, Massachusetts, USA\] or OCT \[Abbott Vascular\], St. Paul, MN, USA\]).

Study summary

Multicenter FLOW-CMD registry is a prospective, multi-center, registry study.

The aim of the study is to evaluate prognostic implications of coronary microvascular disease (CMD) in patients with ischemic heart disease (IHD) undergoing revascularization decision using FFR or other non-hyperemic pressure ratios.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject must be ≥18 years 2. Patients suspected with IHD 3. Patients undergoing physiologic assessment (CFR, IMR, and FFR) for evaluation of severity of CAD 4. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and he/she or his/her legally authorized representative provides written informed consent to any study related procedure. Exclusion Criteria: 1. Cardiogenic shock (systolic blood pressure \<90mmHg or requiring inotropics to maintain blood pressure \>90mmHg) or cardiac arrest 2. Non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment). 3. Inability to undergo physiologic assessment (CFR, IMR, and FFR) 4. Pregnant or lactating women

Primary outcome measure(s)

  • Patient-oriented composite outcomes (POCO) — 1 year after last patient enrollment
    a composite of all-cause death, MI, any repeat revascularization, or admission for heart failure

Trial sites (7)

FacilityCityRegionStatus
Chonnam National University Hospital Gwangju South Korea
Chosun University Hospital Gwangju South Korea
Gyeongsang National University Hospital Jinju South Korea
Seoul National University Bundang Hospital Seongnam South Korea
Samsung Medical Center Seoul South Korea
Seoul National University Boramae Medical Center Seoul South Korea
Seoul St. Mary's Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05369182 on ClinicalTrials.gov ↗ ← All trials in South Korea