CCTA-FFR Registry for Risk Prediction
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

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.
    

Intervention name(s): Fractional flow reserve, Coronary CT angiography
Intervention type(s): Diagnostic Test
Intervention description(s): Coronary CT angiography was performed as part of routine clinical practice for patients with suspected coronary artery disease and the decision to perform coronary CT angiography before invasive angiography was at the judgment of the physicians in charge.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspected coronary artery disease who underwent coronary CT angiography
        within 90 days before FFR measurement will be included.
      
Keywords: Fractional flow reserve; Coronary CT angiography; Atherosclerosis