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

August 24, 2017 updated by: Bon-Kwon Koo, Seoul National University Hospital

Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Fuwai Hospital
      • Guandong, China
        • Guandong General Hospital
      • Hong Kong, China
        • United Christian Hospital
      • Hong Kong, China
        • Queen Mary Hospital, the University of Hong Kong
      • Nanjing, China
        • Nanjing 1st Hospital
      • Zhejiang, China
        • Zhejiang No 2 hospital
  • Japan
      • Gifu, Japan
        • Gifu Heart Center
      • Kita-Kyushu, Japan
        • Kokura Memorial Hospital
      • Kyoto, Japan
        • 2nd Red Cross hospital
      • Nagakute, Japan
        • Aichi Medical University Hospital
      • Tokyo, Japan
        • Tokyo medical college hospital
      • Wakayama, Japan
        • Wakayama Medical University
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Ilsan, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital, Seoul, Korea
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
  • Singapore
      • Singapore, Singapore
        • National University Heart center
  • Taiwan
      • Taipei city, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years after FFR measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (ESTIMATE)

June 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1203-087-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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