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BMC Cardiovasc Disord. 2016 Oct 6;16(1):190.

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

Author information

1
Dalio Institute of Cardiovascular Imaging, NewYork-Presbyterian Hospital, New York, NY, USA.
2
Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands.
3
Department of Medical Imaging, University of British Columbia, St. Paul's Hospital, Vancouver, BC, Canada.
4
Emory University School of Medicine, Atlanta, GA, USA.
5
Centro Cardiologico Monzino, IRCCS, Milan, Italy.
6
Istituto di Ricovero e Cura a Carattere Scientifico, Centro Cardiologico Monzino, Milan, Italy.
7
Davis Heart and Lung Research Institute and Heart Center, The Ohio State University, Columbus, OH, USA.
8
The Cardiac Center of Texas, McKinney, TX, USA.
9
Heart Center Research, LLC, Huntsville, AL, USA.
10
Houston Methodist DeBakey Heart & Vascular Center, Houston Methodist Hospital, Houston, TX, USA.
11
Fondazione Toscana/CNR Gabriele Monasterio, Pisa, Italy.
12
Division of Cardiology, Kaiser Permanente San Jose Medical Center, San Jose, CA, USA.
13
Mobile Cardiology Associates, Mobile, AL, USA.
14
Cardiovascular Imaging Lab, St. Luke's International Hospital, Tokyo, Japan.
15
Heart Flow, Inc., Redwood City, CA, USA.
16
Department of Surgery, Stanford University, Stanford, CA, USA.
17
Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
18
Department of Radiology, Weill Cornell Medical College, New York, NY, USA.
19
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.
20
Dalio Institute of Cardiovascular Imaging, NewYork-Presbyterian Hospital, New York, NY, USA. jkm2001@med.cornell.edu.
21
Department of Medicine, Weill Cornell Medical College, New York, NY, USA. jkm2001@med.cornell.edu.
22
Department of Radiology, Weill Cornell Medical College, New York, NY, USA. jkm2001@med.cornell.edu.
23
Radiology and Medicine, New York-Presbyterian Hospital and Weill Cornell Medical College, 413 E. 69th Street, Suite 108, New York, NY, 10021, USA. jkm2001@med.cornell.edu.

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.

KEYWORDS:

Coronary artery disease; Coronary computed tomography angiography; Fractional flow reserve; Myocardial blood flow; Myocardial perfusion scintigraphy

PMID:
27716131
PMCID:
PMC5053174
DOI:
10.1186/s12872-016-0360-x
[Indexed for MEDLINE]
Free PMC Article

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