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

Asim Rizvi, Bríain Hartaigh, Paul Knaapen, Jonathon Leipsic, Leslee J. Shaw, Daniele Andreini, Gianluca Pontone, Subha Raman, Muhammad Akram Khan, Michael Ridner, Faisal Nabi, Alessia Gimelli, James Jang, Jason Cole, Ryo Nakazato, Christopher Zarins, Donghee Han, Ji Hyun Lee, Jackie Szymonifika, Millie J. GomezQuynh A. Truong, Hyuk Jae Chang, Fay Y. Lin, James K. Min

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)

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.

Original languageEnglish
Article number190
JournalBMC Cardiovascular Disorders
Volume16
Issue number1
DOIs
Publication statusPublished - 2016 Oct 6

Bibliographical note

Funding Information:
We would like to acknowledge and thank all the members of the laboratory teams. Principal Investigators: Andrejs Erglis, MD, Paul Stradins Clinical University Hospital, Riga, Latvia; Erick Avelar, MD, Oconee Heart and Vascular Center at St Mary's Hospital, Athens, GA; U Joseph Schoepf, MD, Medical University of South Carolina, Charleston, SC; Randall Thompson, MD, St. Luke's Mid America Heart Institute, Kansas City, MO; Bin Lu, MD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Beijing, China; Atizazul Mansoor, MD, PinnacleHealth Cardiovascular Institute, Wormleysburg, PA; Chris Rowan, MD, Renown Heart and Vascular, Reno, NV; Philippe G?n?reux, MD, Cardiovascular Research Foundation, New York, NY. Other Investigators: Hiroyuki Niinuma, MD PhD, Cardiovascular Imaging Lab, St. Luke's International Hospital, Tokyo, Japan; Ae-Young Her, MD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Joon-Hyung Doh, MD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Jung Hyun Choi, MD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; So-Yeon Choi, MD PhD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Bon-Kwon Koo, MD PhD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Chang-Wook Nam, MD PhD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Sanghoon Shin, MD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Hyung-Bok Park, MD, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea; Daniel H. Steinberg, MD, Medical University of South Carolina, Charleston, SC; Irfan Ullah, MD CCRP, Cardiac Center of Texas, Mczkinney, TX; Ahmed Ladak, MD CCRP, Cardiac Center of Texas, Mczkinney, TX; Venkata S. Chilakapati, MD FACC, Cardiac Center of Texas, Mczkinney, TX; Dante Chiappino, MD, Fondazione Toscana/CNR Gabriele Monasterio, Pisa PI, Italy; Yang Gao, MD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Beijing, China; Chaowei Mu, MD, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Beijing, China. This study was supported in part by a grant from the National Institutes of Health (R01HL118019). This study was also funded, in part, by a generous gift from the Dalio Institute of Cardiovascular Imaging and the Michael Wolk Foundation.

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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