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

NCT05369182 | Active Not Recruiting DMC

• 1 other identifier: MulticenterFLOW
• Study Type: observational
• Target: 1,003
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Coronary Microvascular Disease; Coronary Artery Disease; Ischemic Heart Disease

Keywords

Coronary Microvascular Disease; Coronary Artery Disease; Ischemic Heart Disease; Coronary Flow Reserve; Index of Microcirculatory Resistance; Fractional Flow Reserve; Intravascular Ultrasound; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Patient-oriented composite outcomes (POCO)

  a composite of all-cause death, MI, any repeat revascularization, or admission for heart failure

  1 year after last patient enrollment

Secondary Outcomes (13)

• All-cause death

  1 year after last patient enrollment

• Cardiac death

  1 year after last patient enrollment

• Target-vessel MI

  1 year after last patient enrollment

• Non-target vessel MI

  1 year after last patient enrollment

• Any MI

  1 year after last patient enrollment

Study Arms (4)

Total Population: Patients with CMD (CFR<2.0 and IMR≥25)

Among the enrolled patients, those who are diagnosed with CMD (CFR\<2.0, IMR≥25) in physiologic assessment.

Diagnostic Test: Invasive physiologic assessment

Total Population: Patients with preserved microvascular function (CFR≥2.0 OR IMR<25)

Among the enrolled patients, those who are with preserved microvascular function (CFR≥2.0 OR IMR\<25) in physiologic assessment.

Diagnostic Test: Invasive physiologic assessment

Revascularized Population: Patients treated by intravascular imaging-guided PCI optimization

Among patients who received PCI, patients whose PCI was optimized through intravascular imaging device (IVUS or OCT).

Diagnostic Test: Invasive physiologic assessment; Diagnostic Test: Intravascular imaging

Revascularized Population: Patients treated by angiography-only guided PCI

Among patients who received PCI, patients whose PCI was optimized through angiography-only.

Diagnostic Test: Invasive physiologic assessment

Interventions

Invasive physiologic assessment DIAGNOSTIC_TEST

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.

Revascularized Population: Patients treated by angiography-only guided PCI; Revascularized Population: Patients treated by intravascular imaging-guided PCI optimization; Total Population: Patients with CMD (CFR<2.0 and IMR≥25); Total Population: Patients with preserved microvascular function (CFR≥2.0 OR IMR<25)

Intravascular imaging DIAGNOSTIC_TEST

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\]).

Revascularized Population: Patients treated by intravascular imaging-guided PCI optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected IHD undergoing invasive coronary angiography and clinically indicated physiological assessment will be eligible. A total of 1,003 patients will be enrolled at 7 centers in South Korea.

You may qualify if:

• Subject must be ≥18 years
• Patients suspected with IHD
• Patients undergoing physiologic assessment (CFR, IMR, and FFR) for evaluation of severity of CAD
• 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.

You may not qualify if:

• Cardiogenic shock (systolic blood pressure \<90mmHg or requiring inotropics to maintain blood pressure \>90mmHg) or cardiac arrest
• Non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment).
• Inability to undergo physiologic assessment (CFR, IMR, and FFR)
• Pregnant or lactating women

Sponsors & Collaborators

• Samsung Medical Center: lead
• Chonnam National University Hospital: collaborator
• Chosun University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator

Study Sites (7)

Chonnam National University Hospital

Gwangju, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Microvascular Angina; Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 11, 2022
• Study Start: April 22, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication of first manuscript and trial results
• Access Criteria: The de-identified data will be shared by permission of principle investigator, when asked

Locations

KR (7)