NCT03690713

International Collaboration of Comprehensive Physiologic Assessment

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,397 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: —
• Age: —
• Healthy volunteers: —

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.

Conditions

• Stable Angina
• Unstable Angina
• Non-ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-06-01
• Completion: 2018-09-26
• First posted: 2018-10-01
• Last updated: 2018-10-02

Locations

4 sites across 3 countries: Japan, South Korea, Spain