Design and rationale of randomized CT-PRECISION study.

Abstract

Coronary computed tomography angiography (CCTA) combined with dynamic CT myocardial perfusion imaging (CT-MPI) and CCTA combined with CT fractional flow reserve (CT-FFR) are both expected to be efficient one-stop shop imaging strategies to guide clinical management. The aim of the study is to determine which of these two methods has superiority in terms of guiding treatment in patients with intermediate to high pretest probability of coronary artery disease (CAD). CT-PRECISION (Computed Tomography myocardial PeRfusion imaging vErsus Computed tomography derived fractional flow reServe: impact ON guiding treatment and prognosis in patients with intermediate to high pretest probability of CAD) is a multicenter, prospective, open-label, randomized study to directly compare the clinical value of guiding treatment and prognostic discrimination of CCTA + dynamic CT-MPI strategy and CCTA + CT-FFR strategy in patients with intermediate to high pretest probability of CAD. Four hundred and twelve patients will be enrolled in this study and randomized to CCTA + dynamic CT-MPI arm and CCTA + CT-FFR arm. All patients will be followed up for at least 2 years. The primary endpoint is the rate of unnecessary invasive coronary angiography (ICA) within 90 days, which is defined as ICA without revascularization. The secondary endpoints will include: (I) a composite of major adverse cardiac events (MACE, defined as all-cause mortality, non-fatal myocardial infarction, rehospitalization due to aggravated angina symptoms, and late revascularization); (II) symptom change at 1 year; (III) the rate of late revascularization after CT examination; (IV) reclassification rate of CCTA + dynamic CT-MPI and CCTA + CT-FFR guided strategies compared with CCTA alone; (V) overall radiation dose, contrast media usage and medical cost. The study will provide valuable information about the optimal CT-based diagnostic strategy with regard to the clinical management of patients with intermediate to high pretest probability of CAD. The study is registered at Chinese Clinical Trial Registry (ChiCTR) with the identifier number ChiCTR2000041102. The first enrollment is planned for January 2021.