International Collaboration of Comprehensive Physiologic Assessment
NCT ID: NCT03690713
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1397 participants
OBSERVATIONAL
2018-06-01
2018-09-26
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient and Vessels underwent physiologic evaluation
The total 1397 patients (1694 vessels) which evaluated using pressure-temperature sensor wire and measured FFR, CFR, and IMR.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* left ventricular dysfunction
* culprit vessel of acute coronary syndrome
No
Sponsors
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Samsung Medical Center
OTHER
Tsuchiura Kyodo General Hospital
OTHER
Hospital San Carlos, Madrid
OTHER
Imperial College Healthcare NHS Trust
OTHER
Tokyo Medical and Dental University
OTHER
Sungkyunkwan University
OTHER
Inje University
OTHER
Keimyung University Dongsan Medical Center
OTHER
Ulsan University Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Bon-Kwon Koo
Professor
Principal Investigators
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Bon-Kwon Koo, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Javier Escaned, MD, PhD
Role: STUDY_CHAIR
Hospital Clinico San Carlos, Madrid, Spain
Tsunekazu Kakuta, MD, PhD
Role: STUDY_CHAIR
Tokyo Medical and Dental University, Tokyo, Japan
Joo Myung Lee, MD, MPH, PhD
Role: STUDY_CHAIR
Samsung Medical Center, Seoul, Korea
Locations
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Tokyo Medical and Dental University
Tokyo, , Japan
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Clinico San Carlos, Madrid, Spain
Madrid, , Spain
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NCT186918690001
Identifier Type: -
Identifier Source: org_study_id
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