Overview

This trial is active, not recruiting.

Condition multivessel coronary artery disease
Sponsor Seoul National University Hospital
Collaborator Ajou University School of Medicine
Start date May 2012
End date March 2015
Trial size 1136 participants
Trial identifier NCT01621438, H-1203-087-402

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

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
time frame: 2 years after FFR measurement

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator Bon-Kwon Koo, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.