Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

NCT01621438 | Unknown DMC

• 1 other identifier: H-1203-087-402
• Study Type: observational
• Target: 1,136
• Locations: 5 countries
• Sites: 20

Brief Summary

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

Conditions

Multivessel Coronary Artery Disease

Keywords

coronary artery; atherosclerosis; angina pectoris

Outcome Measures

Primary Outcomes (1)

• The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR

  2 years after FFR measurement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with 3-vessel intermediate coronary artery disease (visually 30\~70% stenosis in coronary angiogram) whose FFR was measured at all 3-vessels due to their own clinical needs.

You may qualify if:

• Subject must be at least 18 years of age.
• 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.

You may not qualify if:

• Depressed left ventricular systolic function (ejection fraction \< 35%)
• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Inje University: collaborator
• Fu Wai Hospital, Beijing, China: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Tokyo medical college hospital, Japan: collaborator
• Kokura Memorial Hospital: collaborator
• Gifu Heart Center: collaborator
• Aichi Medical University: collaborator
• Wakayama Medical University: collaborator
• Queen Mary Hospital, Hong Kong: collaborator
• United Christian Hospital: collaborator
• National University Heart Centre, Singapore: collaborator
• National Taiwan University Hospital: collaborator
• Nagoya Daini Nesseki Hospital: collaborator
• Ulsan University Hospital: collaborator
• Ajou University School of Medicine: collaborator

Study Sites (20)

Fuwai hospital

Beijing, China

Location

Guandong general hospital

Guandong, China

Location

Queen Mary Hospital, The University of Hong Kong

Hong Kong, China

Location

United Christian Hospital

Hong Kong, China

Location

Nanjing 1st hospital

Nanjing, China

Location

Zhejiang No 2 hospital

Zhejiang, China

Location

Gifu heart center

Gifu, Japan

Location

Kokura memorial hospital

Kitakyushu, Japan

Location

2nd Red Cross hospital

Kyoto, Japan

Location

Aichi Medical university hospital

Nagakute, Japan

Location

Tokyo medical college hospital

Tokyo, Japan

Location

Wakayama medical university

Wakayama, Japan

Location

National University Heart center

Singapore, Singapore

Location

Keimyung University Dongsan medical center

Daegu, South Korea

Location

Inje university Ilsan Paik hospital

Ilsan, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital, Seoul, Korea

Seoul, South Korea

Location

Ajou university hospital

Suwon, South Korea

Location

Ulsan university hospital

Ulsan, South Korea

Location

National Taiwan University hospital

Taipei, Taiwan

Location

Related Publications (9)

• 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.

  PMID: 32914672 DERIVED

• 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.

  PMID: 31097161 DERIVED

• 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.

  PMID: 30813812 DERIVED

• 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.

  PMID: 30586749 DERIVED

• 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.

  PMID: 29449274 DERIVED

• 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.

  PMID: 29361444 DERIVED

• 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.

  PMID: 29146670 DERIVED

• 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.

  PMID: 28862970 DERIVED

• 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.

  PMID: 27609817 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Angina Pectoris

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bon-Kwon Koo, MD

  Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 18, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2018
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

TW (1); CN (6); KR (6); JP (6); SG (1)