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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01621438
Recruitment Status : Unknown
Verified August 2017 by Bon-Kwon Koo, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 18, 2012
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital

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
Multivessel Coronary Artery Disease

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

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Study Type : Observational
Estimated 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 2012
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine





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 [ Time Frame: 2 years after FFR measurement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621438


Locations
Show Show 20 study locations
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
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Principal Investigator: Bon-Kwon Koo, MD Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01621438    
Other Study ID Numbers: H-1203-087-402
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Keywords provided by Bon-Kwon Koo, Seoul National University Hospital:
coronary artery
atherosclerosis
angina pectoris
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases