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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01621438
Collaborator
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 (Other), 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)
1,136
Enrollment
20
Locations
76
Duration (Months)
56.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed.

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1136 participants
    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
    Study Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2015
    Anticipated Study Completion Date :
    Sep 1, 2018

    Outcome Measures

    Primary Outcome Measures

    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

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Fuwai hospital Beijing China
    2 Guandong general hospital Guandong China
    3 Queen Mary Hospital, The University of Hong Kong Hong Kong China
    4 United Christian Hospital Hong Kong China
    5 Nanjing 1st hospital Nanjing China
    6 Zhejiang No 2 hospital Zhejiang China
    7 Gifu heart center Gifu Japan
    8 Kokura memorial hospital Kita-Kyushu Japan
    9 2nd Red Cross hospital Kyoto Japan
    10 Aichi Medical university hospital Nagakute Japan
    11 Tokyo medical college hospital Tokyo Japan
    12 Wakayama medical university Wakayama Japan
    13 Keimyung University Dongsan medical center Daegu Korea, Republic of
    14 Inje university Ilsan Paik hospital Ilsan Korea, Republic of
    15 Samsung Medical Center Seoul Korea, Republic of
    16 Seoul National University Hospital, Seoul, Korea Seoul Korea, Republic of
    17 Ajou university hospital Suwon Korea, Republic of
    18 Ulsan university hospital Ulsan Korea, Republic of
    19 National University Heart center Singapore Singapore
    20 National Taiwan University hospital Taipei city Taiwan

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Bon-Kwon Koo, MD, Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bon-Kwon Koo, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01621438
    Other Study ID Numbers:
    • H-1203-087-402
    First Posted:
    Jun 18, 2012
    Last Update Posted:
    Aug 25, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Bon-Kwon Koo, Professor, Seoul National University Hospital
    coronary artery
    atherosclerosis
    angina pectoris
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Aug 25, 2017