Rationale and design of the dual-energy computed tomography for ischemia determination compared to “gold standard” non-invasive and invasive techniques (DECIDE-Gold) : a multicenter international efficacy diagnostic study of rest-stress dual-energy computed tomography angiography with perfusion

Background: Dual-energy CT (DECT) has potential to improve myocardial perfusion for physiologic assessment of coronary artery disease (CAD). Diagnostic performance of rest-stress DECT perfusion (DECTP) is unknown. Objective: DECIDE-Gold is a prospective multicenter study to evaluate the accuracy of DECT to detect hemodynamic (HD) significant CAD, as compared to fractional flow reserve (FFR) as a reference standard. Methods: Eligible participants are subjects with symptoms of CAD referred for invasive coronary angiography (ICA). Participants will undergo DECTP, which will be performed by pharmacological stress, and participants will subsequently proceed to ICA and FFR. HD-significant CAD will be defined as FFR ≤ 0.80. In those undergoing myocardial stress imaging (MPI) by positron emission tomography (PET), single photon emission computed tomography (SPECT) or cardiac magnetic resonance (CMR) imaging, ischemia will be graded by % ischemic myocardium. Blinded core laboratory interpretation will be performed for CCTA, DECTP, MPI, ICA, and FFR. Results: Primary endpoint is accuracy of DECTP to detect ≥1 HD-significant stenosis at the subject level when compared to FFR. Secondary and tertiary endpoints are accuracies of combinations of DECTP at the subject and vessel levels compared to FFR and MPI. Conclusion: DECIDE-Gold will determine the performance of DECTP for diagnosing ischemia.