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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ajou University School of Medicine
Keimyung University Dongsan Medical Center
Inje University
Fu Wai Hospital, Beijing, China
Nanjing 1st hospital, China
Zhejiang No 2 hospital, China
Guangdong General Hospital
Tokyo medical college hospital, Japan
Kokura memorial hospital, Japan
Gifu heart center, Japan
Aichi Medical University
Wakayama Medical University
Queen Mary Hospital, Hong Kong
United Christian Hospital
National University Heart Centre, Singapore
National Taiwan University Hospital
2nd Red Cross hospital, Japan
Ulsan University Hospital
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01621438
First received: June 7, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition
Multivessel Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR [ Time Frame: 2 years after FFR measurement ] [ Designated as safety issue: No ]

Estimated Enrollment: 1136
Study Start Date: May 2012
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621438

Contacts
Contact: Bon-Kwon Koo, MD 82-2-2072-2062 bkkoo@snu.ac.kr

Locations
China
Fuwai hospital Not yet recruiting
Beijing, China
Contact: Jie Qian         
Guandong general hospital Not yet recruiting
Guandong, China
Contact: Jiyan Chen         
Contact: Yang Junqing         
United Christian Hospital Not yet recruiting
Hong Kong, China
Contact: Chi-Kin Chan         
Queen Mary Hospital, The University of Hong Kong Not yet recruiting
Hong Kong, China
Contact: Stephen Lee         
Contact: Simon Cheung Chi Lam         
Nanjing 1st hospital Not yet recruiting
Nanjing, China
Contact: Shaoliang Chen         
Contact: Fei Ye         
Zhejiang No 2 hospital Not yet recruiting
Zhejiang, China
Contact: JianAn Wang         
Contact: Xinyang Hu         
Japan
Gifu heart center Not yet recruiting
Gifu, Japan
Contact: Hitoshi Matsuo         
Kokura memorial hospital Not yet recruiting
Kita-Kyushu, Japan
Contact: Hiroyoshi Yokoi         
2nd Red Cross hospital Not yet recruiting
Kyoto, Japan
Contact: Hiroshi Fujita         
Aichi Medical university hospital Not yet recruiting
Nagakute, Japan
Contact: Hiroaki Takashima         
Tokyo medical college hospital Not yet recruiting
Tokyo, Japan
Contact: Nob Tanaka         
Wakayama medical university Not yet recruiting
Wakayama, Japan
Contact: Takashi Akasaka         
Contact: Yasutsugu Shiono         
Korea, Republic of
Keimyung University Dongsan medical center Not yet recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam         
Inje university Ilsan Paik hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: Jun-Hyung Doh         
Seoul National University Hospital, Seoul, Korea Recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MD    82-2-2072-2062    bkkoo@snu.ac.kr   
Ajou university hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: Seung-Jea Tahk, MD         
Ulsan university hospital Not yet recruiting
Ulsan, Korea, Republic of
Contact: Eun-Seok Shin         
Singapore
National University Heart center Not yet recruiting
Singapore, Singapore
Contact: Adrian Low         
Contact: Ronald Lee         
Taiwan
National Taiwan University hospital Not yet recruiting
Taipei city, Taiwan
Contact: Tzung-Dau Wang         
Sponsors and Collaborators
Seoul National University Hospital
Ajou University School of Medicine
Keimyung University Dongsan Medical Center
Inje University
Fu Wai Hospital, Beijing, China
Nanjing 1st hospital, China
Zhejiang No 2 hospital, China
Guangdong General Hospital
Tokyo medical college hospital, Japan
Kokura memorial hospital, Japan
Gifu heart center, Japan
Aichi Medical University
Wakayama Medical University
Queen Mary Hospital, Hong Kong
United Christian Hospital
National University Heart Centre, Singapore
National Taiwan University Hospital
2nd Red Cross hospital, Japan
Ulsan University Hospital
Investigators
Principal Investigator: Bon-Kwon Koo, MD Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01621438     History of Changes
Other Study ID Numbers: H-1203-087-402
Study First Received: June 7, 2012
Last Updated: June 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
coronary artery
atherosclerosis
angina pectoris

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014