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Clinical Trial
. 2016 Oct 6;16(1):190.
doi: 10.1186/s12872-016-0360-x.

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

Asim Rizvi  1 , Bríain Ó Hartaigh  1 , Paul Knaapen  2 , Jonathon Leipsic  3 , Leslee J Shaw  4 , Daniele Andreini  5 , Gianluca Pontone  6 , Subha Raman  7 , Muhammad Akram Khan  8 , Michael Ridner  9 , Faisal Nabi  10 , Alessia Gimelli  11 , James Jang  12 , Jason Cole  13 , Ryo Nakazato  14 , Christopher Zarins  15   16 , Donghee Han  1 , Ji Hyun Lee  1 , Jackie Szymonifika  1 , Millie J Gomez  1 , Quynh A Truong  1   17   18 , Hyuk-Jae Chang  19 , Fay Y Lin  1   18 , James K Min  20   21   22   23
Affiliations
Clinical Trial

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

Asim Rizvi et al. BMC Cardiovasc Disord. .

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.

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Figures

Fig. 1
Fig. 1
CREDENCE study design. CAD, coronary artery disease; ICA, invasive coronary angiography; CCTA, coronary computed tomography angiography; MPS, myocardial perfusion scintigraphy; FFR, fractional flow reserve; FFRCT, fractional flow reserve derived from coronary computed tomography angiography; APCs, atherosclerotic plaque characteristics; PCI, percutaneous coronary intervention
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