TY - JOUR
T1 - Rationale and Design of the CREDENCE Trial
T2 - Computed TomogRaphic evaluation of atherosclerotic DEtermiNants of myocardial IsChEmia
AU - Rizvi, Asim
AU - Hartaigh, Bríain
AU - Knaapen, Paul
AU - Leipsic, Jonathon
AU - Shaw, Leslee J.
AU - Andreini, Daniele
AU - Pontone, Gianluca
AU - Raman, Subha
AU - Khan, Muhammad Akram
AU - Ridner, Michael
AU - Nabi, Faisal
AU - Gimelli, Alessia
AU - Jang, James
AU - Cole, Jason
AU - Nakazato, Ryo
AU - Zarins, Christopher
AU - Han, Donghee
AU - Lee, Ji Hyun
AU - Szymonifika, Jackie
AU - Gomez, Millie J.
AU - Truong, Quynh A.
AU - Chang, Hyuk Jae
AU - Lin, Fay Y.
AU - Min, James K.
N1 - Publisher Copyright:
© 2016 The Author(s).
PY - 2016/10/6
Y1 - 2016/10/6
N2 - 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.
AB - 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.
KW - Coronary artery disease
KW - Coronary computed tomography angiography
KW - Fractional flow reserve
KW - Myocardial blood flow
KW - Myocardial perfusion scintigraphy
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U2 - 10.1186/s12872-016-0360-x
DO - 10.1186/s12872-016-0360-x
M3 - Article
C2 - 27716131
AN - SCOPUS:84991214037
SN - 1471-2261
VL - 16
JO - BMC Cardiovascular Disorders
JF - BMC Cardiovascular Disorders
IS - 1
M1 - 190
ER -