Rationale and Design of the CREDENCE Trial: Computed TomogRaphic evaluation of atherosclerotic DEtermiNants of myocardial IsChEmia

• Type of Material: Article
• Authors: Asim Rizvi, New York Presbyterian Hospital; Bríain ó. Hartaigh, New York Presbyterian Hospital; Paul Knaapen, VU University Medical Center; Jonathon Leipsic, The University of British Columbia; Leslee Shaw, Emory University; Daniele Andreini, IRCCS Centro Cardiologico Monzino; Gianluca Pontone, IRCCS Centro Cardiologico Monzino; Subha Raman, Ohio State University; Muhammad Akram Khan, The Cardiac Center of Texas; Michael Ridner, Heart Center Research; Faisal Nabi, Methodist Hospital Houston; Alessia Gimelli, Consiglio Nazionale delle Ricerche; James Jang, San Jose Medical Center; Jason Cole, Cardiology Associates of Mobile; Ryo Nakazato, St. Luke's International Hospital Tokyo; Christopher Zarins, HeartFlow Inc.; Donghee Han, New York Presbyterian Hospital; Ji Hyun Lee, New York Presbyterian Hospital; Jackie Szymonifika, New York Presbyterian Hospital; Millie J. Gomez, New York Presbyterian Hospital; Quynh A. Truong, New York Presbyterian Hospital; Hyuk-Jae Chang, Yonsei University Health System; Fay Y. Lin, New York Presbyterian Hospital; James K. Min, New York Presbyterian Hospital
• Language: English
• Date: 2016-10-06
• Publisher: BioMed Central
• Publication Version: Final Published Version
• Copyright Statement: © 2016 The Author(s). The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s12872-016-0360-x
• Title of Journal or Parent Work: BMC Cardiovascular Disorders
• ISSN: 1471-2261
• Volume: 16
• Issue: 1
• Start Page: 190
• End Page: 190
• Grant/Funding Information: This study was also funded, in part, by a generous gift from the Dalio Institute of Cardiovascular Imaging and the Michael Wolk Foundation.; This study was supported in part by a grant from the National Institutes of Health (R01HL118019).
• Keywords: Myocardial blood flow; Cardiology; Fractional flow reserve; Coronary artery disease; Myocardial perfusion scintigraphy; Coronary computed tomography angiography
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Radiology

Abstract

Background: Coronary computed tomography angiography (CCTA) allows for non-invasive assessment of obstructive coronary artery disease (CAD) beyond measures of stenosis severity alone. This assessment includes atherosclerotic plaque characteristics (APCs) and calculation of fractional flow reserve (FFR) from CCTA (FFRCT). Similarly, stress imaging by myocardial perfusion scintigraphy (MPS) provides vital information. To date, the diagnostic performance of integrated CCTA assessment versus integrated MPS assessment for diagnosis of vessel-specific ischemia remains underexplored. Methods: CREDENCE will enroll adult individuals with symptoms suspicious of CAD referred for non-emergent invasive coronary angiography (ICA), but without known CAD. All participants will undergo CCTA, MPS, ICA and FFR. FFR will be performed for lesions identified at the time of ICA to be ≥40 and <90 % stenosis, or those clinically indicated for evaluation. Study analyses will focus on diagnostic performance of CCTA versus MPS against invasive FFR reference standard. An integrated stenosis-APC-FFRCT metric by CCTA for vessel-specific ischemia will be developed from derivation cohort and tested against a validation cohort. Similarly, integrated metric by MPS for vessel-specific ischemia will be developed, validated and compared. An FFR value of ≤0.80 will be considered as ischemia causing. The primary endpoint will be the diagnostic accuracy of vessel territory-specific ischemia of integrated stenosis-APC-FFRCT measure by CCTA, compared with perfusion or perfusion-myocardial blood flow stress imaging testing, against invasive FFR. Discussion: CREDENCE will determine the performance of integrated CCTA metric compared to integrated MPS measure for diagnosis of vessel-specific ischemia. If proven successful, this study may reduce the number of missed diagnoses and help to optimally predict ischemia-causing lesions. Trial registration: ClinicalTrials.gov, NCT02173275. Registered on June 23, 2014.