Clinical trial NCT03690713: International Collaboration of Comprehensive Physiologic Assessment
Official title: International Patient-level Pooled Analysis of Comprehensive Physiologic Assessment: Collaborating Project of Korea, Japan, and Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Unstable Angina
Non-ST Elevation Myocardial Infarction
ST-segment Elevation Myocardial Infarction
Keywords: fractional flow reserve
myocardial ischemia
coronary artery disease
coronary flow reserve
index of microcirculatory resistance
prognosis
percutaneous coronary intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Tsuchiura Kyodo General Hospital
name: Hospital San Carlos, Madrid
name: Imperial College Healthcare NHS Trust
name: Tokyo Medical and Dental University
name: Sungkyunkwan University
name: Inje University
name: Keimyung University Dongsan Medical Center
name: Ulsan University Hospital
First posted: 2018-10-01
Enrollment: 1397
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
timeFrame: 5 year
measure: Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
timeFrame: 5 year
Secondary outcomes:
measure: Cumulative incidence of any death
timeFrame: 5 year
measure: Cumulative incidence of cardiac death
timeFrame: 5 year
measure: Cumulative incidence of myocardial infarction
timeFrame: 5 year
measure: Cumulative incidence of ischemia-driven revascularization
timeFrame: 5 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos, Madrid, Spain
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Clinico San Carlos, Madrid, Spain
name: Javier Escaned, MD, PhD
role: STUDY_CHAIR
affiliation: Tokyo Medical and Dental University, Tokyo, Japan
name: Tsunekazu Kakuta, MD, PhD
role: STUDY_CHAIR
affiliation: Samsung Medical Center, Seoul, Korea
name: Joo Myung Lee, MD, MPH, PhD
role: STUDY_CHAIR
References:
citation: Shin D, Lee JM, Lee SH, Hwang D, Choi KH, Kim HK, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J, Koo BK. Non-randomized comparison between revascularization and deferral for intermediate coronary stenosis with abnormal fractional flow reserve and preserved coronary flow reserve. Sci Rep. 2021 Apr 28;11(1):9126. doi: 10.1038/s41598-021-88732-4.
citation: Lee JM, Choi KH, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J, Koo BK. Long-term Patient Prognostication by Coronary Flow Reserve and Index of Microcirculatory Resistance: International Registry of Comprehensive Physiologic Assessment. Korean Circ J. 2020 Oct;50(10):890-903. doi: 10.4070/kcj.2020.0083. Epub 2020 May 27.
citation: Hamaya R, Lee JM, Hoshino M, Yonetsu T, Koo BK, Escaned J, Kakuta T; Collaborators. Clinical outcomes of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention By Coronary Flow Capacity Status in Stable Lesions. EuroIntervention. 2021 Jul 20;17(4):e301-e308. doi: 10.4244/EIJ-D-20-00401.
citation: Hamaya R, Hoshino M, Yonetsu T, Lee JM, Koo BK, Escaned J, Kakuta T. Defining heterogeneity of epicardial functional stenosis with low coronary flow reserve by unsupervised machine learning. Heart Vessels. 2020 Nov;35(11):1527-1536. doi: 10.1007/s00380-020-01640-x. Epub 2020 Jun 6.
citation: Lee SH, Lee JM, Park J, Choi KH, Hwang D, Doh JH, Nam CW, Shin ES, Hoshino M, Murai T, Yonetsu T, Mejia-Renteria H, Kakuta T, Escaned J; International Collaboration of Comprehensive Physiologic Assessment Investigators. Prognostic Implications of Resistive Reserve Ratio in Patients With Coronary Artery Disease. J Am Heart Assoc. 2020 Apr 21;9(8):e015846. doi: 10.1161/JAHA.119.015846. Epub 2020 Apr 18.