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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ajou University School of Medicine
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 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
Nagoya Daini Nesseki Hospital
Ulsan University Hospital
Information provided by (Responsible Party):
Bon-Kwon Koo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01621438
First received: June 7, 2012
Last updated: September 23, 2015
Last verified: September 2015
  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

Resource links provided by NLM:


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
Estimated Study Completion Date: September 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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

Locations
China
Fuwai hospital
Beijing, China
Guandong general hospital
Guandong, China
Queen Mary Hospital, The University of Hong Kong
Hong Kong, China
United Christian Hospital
Hong Kong, China
Nanjing 1st hospital
Nanjing, China
Zhejiang No 2 hospital
Zhejiang, China
Japan
Gifu heart center
Gifu, Japan
Kokura memorial hospital
Kita-Kyushu, Japan
2nd Red Cross hospital
Kyoto, Japan
Aichi Medical university hospital
Nagakute, Japan
Tokyo medical college hospital
Tokyo, Japan
Wakayama medical university
Wakayama, Japan
Korea, Republic of
Keimyung University Dongsan medical center
Daegu, Korea, Republic of
Inje university Ilsan Paik hospital
Ilsan, Korea, Republic of
Seoul National University Hospital, Seoul, Korea
Seoul, Korea, Republic of
Ajou university hospital
Suwon, Korea, Republic of
Ulsan university hospital
Ulsan, Korea, Republic of
Singapore
National University Heart center
Singapore, Singapore
Taiwan
National Taiwan University hospital
Taipei city, Taiwan
Sponsors and Collaborators
Seoul National University Hospital
Ajou University School of Medicine
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 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
Nagoya Daini Nesseki Hospital
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

Responsible Party: Bon-Kwon Koo, Professor, 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: September 23, 2015
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 30, 2016