Clinical trial NCT01621438: Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multivessel Coronary Artery Disease
Keywords: coronary artery
atherosclerosis
angina pectoris
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Keimyung University Dongsan Medical Center
name: Inje University
name: Fu Wai Hospital, Beijing, China
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Guangdong Provincial People's Hospital
name: Tokyo medical college hospital, Japan
name: Kokura Memorial Hospital
name: Gifu Heart Center
name: Aichi Medical University
name: Wakayama Medical University
name: Queen Mary Hospital, Hong Kong
name: United Christian Hospital
name: National University Heart Centre, Singapore
name: National Taiwan University Hospital
name: Nagoya Daini Nesseki Hospital
name: Ulsan University Hospital
name: Ajou University School of Medicine
First posted: 2012-06-18
Enrollment: 1136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility 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

Primary outcomes:
measure: The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR
timeFrame: 2 years after FFR measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
city: Guandong
country: China
facility: Guandong general hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital, The University of Hong Kong
city: Hong Kong
country: China
facility: United Christian Hospital
city: Nanjing
country: China
facility: Nanjing 1st hospital
city: Zhejiang
country: China
facility: Zhejiang No 2 hospital
city: Gifu
country: Japan
facility: Gifu heart center
city: Kita-Kyushu
country: Japan
facility: Kokura memorial hospital
city: Kyoto
country: Japan
facility: 2nd Red Cross hospital
city: Nagakute
country: Japan
facility: Aichi Medical university hospital
city: Tokyo
country: Japan
facility: Tokyo medical college hospital
city: Wakayama
country: Japan
facility: Wakayama medical university
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan medical center
city: Ilsan
country: Korea, Republic of
facility: Inje university Ilsan Paik hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Seoul, Korea
city: Suwon
country: Korea, Republic of
facility: Ajou university hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan university hospital
city: Singapore
country: Singapore
facility: National University Heart center
city: Taipei city
country: Taiwan
facility: National Taiwan University hospital
Study officials:
affiliation: Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea
name: Bon-Kwon Koo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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