International Collaboration of Comprehensive Physiologic Assessment

Stable Angina Clinical Trial

Official title:

International Patient-level Pooled Analysis of Comprehensive Physiologic Assessment: Collaborating Project of Korea, Japan, and Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690713
• Other study ID #: NCT186918690001
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: September 26, 2018

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1397
• Est. completion date: September 26, 2018
• Est. primary completion date: June 1, 2018
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction
• Stable Angina
• Unstable Angina

Intervention

Diagnostic Test:
• Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance
The pressure sensor was positioned at the distal segment of a target vessel, and intracoronary nitrate was administered before each physiologic measurement. To derive resting mean transit time (Tmn), a thermodilution curve was obtained by using 3 injections (3-4 mL each) of room-temperature saline. Hyperemic proximal aortic pressure (Pa), distal arterial pressure (Pd), and hyperemic Tmn were measured during sustained hyperemia. CFR was calculated as resting Tmn/hyperemic Tmn. FFR was calculated as the lowest average of 3 consecutive beats during hyperemia. The uncorrected IMR was calculated by Pd × Tmn during hyperaemia. All IMR values were corrected by Yong's formula (Pa × Tmn × ([1.35 × Pd/Pa] - 0.32).

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Tokyo
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Spain	Hospital Clinico San Carlos, Madrid, Spain	Madrid

Sponsors (10)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hospital San Carlos, Madrid, Imperial College Healthcare NHS Trust, Inje University, Keimyung University Dongsan Medical Center, Samsung Medical Center, Sungkyunkwan University, Tokyo Medical and Dental University, Tsuchiura Kyodo General Hospital, Ulsan University Hospital

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization	Patient-oriented composite outcome	5 year
Primary	Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization	Vessel-oriented composite outcome	5 year
Secondary	Cumulative incidence of any death	all-cause mortality	5 year
Secondary	Cumulative incidence of cardiac death	cardiac death	5 year
Secondary	Cumulative incidence of myocardial infarction	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	5 year
Secondary	Cumulative incidence of ischemia-driven revascularization	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	5 year