Quynh A Truong1,2, Paul Knaapen3, Gianluca Pontone4, Daniele Andreini4, Jonathon Leipsic5, Patricia Carrascosa6, Bin Lu7, Kelley Branch8, Subha Raman9, Stephen Bloom10, James K Min11,12. 1. Departments of Radiology, Weill Cornell Medical College, 413 E. 69th Street, Suite 108, New York, NY, 10021, USA. 2. Dalio Institute of Cardiovascular Imaging, New York Presbyterian Hospital, New York, NY, USA. 3. Department of Cardiology, VU Medical Center, Amsterdam, The Netherlands. 4. Centro Cardiologico Monzino, Milan, Italy. 5. Providence Health Care-St. Paul's Hospital, University of British Columbia, Vancouver, Canada. 6. Diagnóstico Maipú, Buenos Aires, Argentina. 7. State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 8. Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA, USA. 9. Division of Cardiology, Department of Medicine, Wexner Heart and Vascular Institute, The Ohio State University, Columbus, OH, USA. 10. Midwest Heart & Vascular Associates, Kansas City, MO, USA. 11. Departments of Radiology, Weill Cornell Medical College, 413 E. 69th Street, Suite 108, New York, NY, 10021, USA. runone123@gmail.com. 12. Dalio Institute of Cardiovascular Imaging, New York Presbyterian Hospital, New York, NY, USA. runone123@gmail.com.
Abstract
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.
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.
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