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Validation of the diagnostic performance of 'HeartMedi V.1.0', a novel CT-derived fractional flow reserve measurement, for patients with coronary artery disease: a study protocol

Title
Validation of the diagnostic performance of 'HeartMedi V.1.0', a novel CT-derived fractional flow reserve measurement, for patients with coronary artery disease: a study protocol
Authors
Kim S.-H.Kang S.-H.Chung W.-Y.Yoon C.-H.Park S.-D.Nam C.-W.Kwon K.-H.Doh J.-H.Byun Y.-S.Bae J.-W.Youn T.-J.Chae I.-H.
Ewha Authors
권기환
SCOPUS Author ID
권기환scopusscopus
Issue Date
2020
Journal Title
BMJ open
ISSN
2044-6055JCR Link
Citation
BMJ open vol. 10, no. 7, pp. e037780
Keywords
cardiovascular imagingcomputed tomographycoronary heart disease
Publisher
NLM (Medline)
Indexed
SCIE; SCOPUS scopus
Document Type
Article
Abstract
INTRODUCTION: Coronary CT angiography (CCTA) is widely used for non-invasive coronary artery evaluation, but it is limited in identifying the nature of functional characteristics that cause ischaemia. Recent computational fluid dynamic (CFD) techniques applied to CCTA images permit non-invasive computation of fractional flow reserve (FFR), a measure of lesion-specific ischaemia. However, this technology has limitations, such as long computational time and the need for expensive equipment, which hinder widespread use. METHODS AND ANALYSIS: This study is a prospective, multicentre, comparative and confirmatory trial designed to evaluate the diagnostic performance of HeartMedi V.1.0, a novel CT-derived FFR measurement for the detection of haemodynamically significant coronary artery stenoses identified by CCTA, based on invasive FFR as a reference standard. The invasive FFR values ≤0.80 will be considered haemodynamically significant. The study will enrol 184 patients who underwent CCTA, invasive coronary angiography and invasive FFR. Computational FFR (c-FFR) will be analysed by CFD techniques using a lumped parameter model based on vessel length method. Blinded core laboratory interpretation will be performed for CCTA, invasive coronary angiography, invasive FFR and c-FFR. The primary objective of the study is to compare the area under the receiver-operator characteristic curve between c-FFR and CCTA to non-invasively detect the presence of haemodynamically significant coronary stenosis. The secondary endpoints include diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value and correlation of c-FFR with invasive FFR. ETHICS AND DISSEMINATION: The study has ethic approval from the ethics committee of Seoul National University Bundang Hospital (E-1709/420-001) and informed consent will be obtained for all enrolled patients. The result will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: KCT0002725; Pre-results. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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DOI
10.1136/bmjopen-2020-037780
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의과대학 > 의학과 > Journal papers
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