CCTA-FFR Registry for Risk Prediction

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Fractional flow reserve, Coronary CT angiography

• Registration Number: NCT04037163
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators sought to investigate the prognostic implication of qualitative and quantitative plaque analysis on coronary CT angiography (CCTA) according to fractional flow reserve (FFR). The main objective was to develop a comprehensive risk model by using clinical risk factors, FFR and CCTA parameters.

Detailed Description

Coronary CT angiography (CCTA) is an evolving noninvasive modality in diagnosis of coronary artery disease (CAD). Its incremental prognostic value over traditional scheme of risk prediction has repeatedly been demonstrated. Beyond the assessment of CAD severity, the prognostic value of CCTA has increased with comprehensive plaque analysis. Certain plaque features on CCTA have a prognostic value in the prediction of future coronary events. The concept of fractional flow reserve (FFR) has been developed as an invasive index of the functional severity of stenosis. FFR represents maximal blood flow to the myocardium supplied by an artery with stenosis as a fraction of normal maximum flow. In moderate stenotic lesion, determining whether to perform PCI based on FFR is a current guideline, and has been proven to reduce unnecessary revascularization procedure and improve clinical prognosis. However, clinical events still occur in patients with FFR \>0.80. In a recent study, the prognosis in the vessel with FFR \> 0.8 was investigated. However, a comprehensive risk model according to FFR has never been investigated. Therefore, the investigators sought to investigate the prognostic implication of qualitative and quantitative plaque analysis on CCTA according to FFR. The main objective was to develop a comprehensive risk model by using clinical risk factors, FFR, and CCTA parameters.

Patients who underwent CCTA within 90 days before FFR measurement will be included. The study population will be from 2 different registries. The 3V-FFR-FRIENDS registry (NCT0620122050) enrolled a total of 1,136 patients (3,298 vessels). Among them, 299 patients who underwent CCTA within 90 days before FFR measurement will be included. The institutional registry of Tsuchiura Kyodo General Hospital included 448 patients who underwent FFR measurement and CCTA within 90 days. By retrospectively collecting clinical outcome data, coronary angiographic data, physiologic indices, and CCTA data from two registries, the CCTA-FFR Registry for Development of Comprehensive Risk Prediction Model will be created. For 3V FFR-FRIENDS registry (NCT0620122050), the collected clinical data for the previous study will be used, and 5-year outcome data will be collected from Seoul National University Hospital, Keimyung University Dongsan Medical Center, and Inje University Ilsan Paik Hospital. For the Institutional registry of Tsuchiura Kyodo General Hospital registry, the investigators will collect the baseline characteristics of participants, CCTA data, and clinical outcome data followed until Mar 2019.

Study Timeline

• Study Start: 2010-12-22
• Primary Completion: 2019-03-31
• Study Completion: 2019-05-31
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-27
• Last Update Submitted: 2019-07-27
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 747

Inclusion Criteria

• Patients who underwent CCTA within 90 days before FFR measurement

Exclusion Criteria

• Unanalyzable coronary CT angiography
• Inadequate fractional flow reserve measurement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCTA-FFR	Fractional flow reserve, Coronary CT angiography	Patients who underwent CCTA within 90 days before FFR measurement will be included in the present study.

Primary Outcome Measures

Name	Time	Method
Discrimination index of prediction model for vessel-oriented composite outcome	Upto 5 years after index procedure	A risk model for vessel-oriented composite outcome, incorporating clinical, angiographic, fractional flow reserve (FFR), and coronary CT angiographic parameters will be developed. Vessel-oriented composite outcome is a composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization. The target vessel will be defined as the vessel with FFR measurement.