International Collaboration of Comprehensive Physiologic Assessment

Completed

• Conditions: ST-segment Elevation Myocardial Infarction; Stable Angina; Unstable Angina; Non-ST Elevation Myocardial Infarction
• Interventions: Diagnostic Test: Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance

• Registration Number: NCT03690713
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).

Detailed Description

The patient-level data was gathered from 3 nations (Korea, Japan, Spain). The total 1397 patients (1694 vessels) data was collected from 5 university hospitals in Korea (Seoul National University Hospital, Samsung Medical Centre, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Centre, and Ulsan University Hospital, Korea) and Tsuchiura Kyodo General Hospital, Ibaraki, Japan, and Hospital Clinico San Carlos, Madrid, Spain.

Standardized form of data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel was included in the data.

Primary outcome is patient- and vessel-oriented composite outcome at 5 years.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-06-01
• Status Verified: 2018-09
• Study Completion: 2018-09-26
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Last Update Submitted: 2018-09-28
• Study First Posted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 1397

Inclusion Criteria

• patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery

Exclusion Criteria

• Patients with hemodynamic instability
• left ventricular dysfunction
• culprit vessel of acute coronary syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient and Vessels underwent physiologic evaluation	Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance	The total 1397 patients (1694 vessels) which evaluated using pressure-temperature sensor wire and measured FFR, CFR, and IMR.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization	5 year	Patient-oriented composite outcome
Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization	5 year	Vessel-oriented composite outcome

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of cardiac death	5 year	cardiac death
Cumulative incidence of myocardial infarction	5 year	MI was defined as elevated cardiac enzyme levels greater than the upper limit of the normal range with either ischemic symptoms or electrocardiography changes indicating ischemia after index procedure. Periprocedural MI was not included as a clinical outcome
Cumulative incidence of ischemia-driven revascularization	5 year	Ischemia-driven revascularization was defined as a revascularization procedure with at least one of the following: (1) recurrence of angina; (2) positive non-invasive test; and (3) positive invasive physiologic test
Cumulative incidence of any death	5 year	all-cause mortality

Trial Locations

Locations (4)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hospital Clinico San Carlos, Madrid, Spain; 🇪🇸 Madrid, Spain

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Tokyo Medical and Dental University; 🇯🇵 Tokyo, Japan