Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
NCT ID: NCT01621438
Last Updated: 2017-08-25
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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UNKNOWN
1136 participants
OBSERVATIONAL
2012-05-31
2018-09-30
Brief Summary
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Detailed Description
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Pre-specified Subgroup Analysis
The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects:
* Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.).
* Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed).
* Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test.
* Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR \<0.75, 0.75-0.80, and \>0.80).
* Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subject must have stenosis (\>30% by visual estimate) in all 3-epicardial coronary arteries.
* FFR should be measured at all 3-vessels at the end of a procedure.
Exclusion Criteria
* ST-elevation myocardial infarction within 72 hours,
* Prior coronary artery bypass graft surgery
* Creatinine level \>= 2.0mg/dL or dependence on dialysis
* Abnormal final myocardial flow (TIMI flow \< 3)
* Planned bypass surgery
* Failed FFR measurement
* Failed intended revascularization
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Keimyung University Dongsan Medical Center
OTHER
Inje University
OTHER
Fu Wai Hospital, Beijing, China
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Guangdong Provincial People's Hospital
OTHER
Tokyo medical college hospital, Japan
UNKNOWN
Kokura Memorial Hospital
OTHER
Gifu Heart Center
OTHER
Aichi Medical University
OTHER
Wakayama Medical University
OTHER
Queen Mary Hospital, Hong Kong
OTHER
United Christian Hospital
OTHER
National University Heart Centre, Singapore
OTHER
National Taiwan University Hospital
OTHER
Nagoya Daini Nesseki Hospital
OTHER
Ulsan University Hospital
OTHER
Ajou University School of Medicine
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
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea
Locations
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Fuwai hospital
Beijing, , China
Guandong general hospital
Guandong, , China
Queen Mary Hospital, The University of Hong Kong
Hong Kong, , China
United Christian Hospital
Hong Kong, , China
Nanjing 1st hospital
Nanjing, , China
Zhejiang No 2 hospital
Zhejiang, , China
Gifu heart center
Gifu, , Japan
Kokura memorial hospital
Kitakyushu, , Japan
2nd Red Cross hospital
Kyoto, , Japan
Aichi Medical university hospital
Nagakute, , Japan
Tokyo medical college hospital
Tokyo, , Japan
Wakayama medical university
Wakayama, , Japan
National University Heart center
Singapore, , Singapore
Keimyung University Dongsan medical center
Daegu, , South Korea
Inje university Ilsan Paik hospital
Ilsan, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital, Seoul, Korea
Seoul, , South Korea
Ajou university hospital
Suwon, , South Korea
Ulsan university hospital
Ulsan, , South Korea
National Taiwan University hospital
Taipei, , Taiwan
Countries
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References
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Lee JM, Lee SH, Hwang D, Rhee TM, Choi KH, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Long-Term Clinical Outcomes of Nonhyperemic Pressure Ratios: Resting Full-Cycle Ratio, Diastolic Pressure Ratio, and Instantaneous Wave-Free Ratio. J Am Heart Assoc. 2020 Sep 15;9(18):e016818. doi: 10.1161/JAHA.120.016818. Epub 2020 Sep 11.
Lee JM, Choi KH, Koo BK, Park J, Kim J, Hwang D, Rhee TM, Kim HY, Jung HW, Kim KJ, Yoshiaki K, Shin ES, Doh JH, Chang HJ, Cho YK, Yoon HJ, Nam CW, Hur SH, Wang J, Chen S, Kuramitsu S, Tanaka N, Matsuo H, Akasaka T. Prognostic Implications of Plaque Characteristics and Stenosis Severity in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2019 May 21;73(19):2413-2424. doi: 10.1016/j.jacc.2019.02.060.
Kim CH, Koo BK, Lee JM, Shin ES, Park J, Choi KH, Hwang D, Rhee TM, Zhang J, Choi YJ, Lee SY, Choi JH, Doh JH, Nam CW, Wang J, Chen S, Kuramitsu S, Tanaka N, Matsuo H, Akasaka T. Influence of Sex on Relationship Between Total Anatomical and Physiologic Disease Burdens and Their Prognostic Implications in Patients With Coronary Artery Disease. J Am Heart Assoc. 2019 Mar 5;8(5):e011002. doi: 10.1161/JAHA.118.011002.
Lee JM, Choi KH, Park J, Hwang D, Rhee TM, Kim J, Park J, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Nam CW, Shin ES, Doh JH, Hur SH, Koo BK. Physiological and Clinical Assessment of Resting Physiological Indexes. Circulation. 2019 Feb 12;139(7):889-900. doi: 10.1161/CIRCULATIONAHA.118.037021.
Park J, Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Zhang J, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical Relevance of Functionally Insignificant Moderate Coronary Artery Stenosis Assessed by 3-Vessel Fractional Flow Reserve Measurement. J Am Heart Assoc. 2018 Feb 15;7(4):e008055. doi: 10.1161/JAHA.117.008055.
Choi KH, Lee JM, Koo BK, Nam CW, Shin ES, Doh JH, Rhee TM, Hwang D, Park J, Zhang J, Kim KJ, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Prognostic Implication of Functional Incomplete Revascularization and Residual Functional SYNTAX Score in Patients With Coronary Artery Disease. JACC Cardiovasc Interv. 2018 Feb 12;11(3):237-245. doi: 10.1016/j.jcin.2017.09.009. Epub 2018 Jan 17.
Kobayashi Y, Lee JM, Fearon WF, Lee JH, Nishi T, Choi DH, Zimmermann FM, Jung JH, Lee HJ, Doh JH, Nam CW, Shin ES, Koo BK. Three-Vessel Assessment of Coronary Microvascular Dysfunction in Patients With Clinical Suspicion of Ischemia: Prospective Observational Study With the Index of Microcirculatory Resistance. Circ Cardiovasc Interv. 2017 Nov;10(11):e005445. doi: 10.1161/CIRCINTERVENTIONS.117.005445.
Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hu X, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Hwang D, Park J, Kim KJ, Akasaka T, Wang J. Clinical Outcomes of Deferred Lesions With Angiographically Insignificant Stenosis But Low Fractional Flow Reserve. J Am Heart Assoc. 2017 Aug 22;6(8):e006071. doi: 10.1161/JAHA.117.006071.
Lee JM, Kim CH, Koo BK, Hwang D, Park J, Zhang J, Tong Y, Jeon KH, Bang JI, Suh M, Paeng JC, Cheon GJ, Na SH, Ahn JM, Park SJ, Kim HS. Integrated Myocardial Perfusion Imaging Diagnostics Improve Detection of Functionally Significant Coronary Artery Stenosis by 13N-ammonia Positron Emission Tomography. Circ Cardiovasc Imaging. 2016 Sep;9(9):e004768. doi: 10.1161/CIRCIMAGING.116.004768.
Other Identifiers
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H-1203-087-402
Identifier Type: -
Identifier Source: org_study_id
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