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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

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Author(s)
Soo-Hyun KimSi-Hyuck KangWoo-Young ChungChang-Hwan YoonSang-Don ParkChang-Wook NamKi-Hwan KwonJoon-Hyung DohYoung-Sup ByunJang-Whan BaeTae-Jin YounIn-Ho Chae
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
BMJ Open
Issued Date
2020
Volume
10
Issue
7
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.
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine (의과대학)
Citation
Soo-Hyun Kim et al. (2020). 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. BMJ Open, 10(7), e037780. doi: 10.1136/bmjopen-2020-037780
Type
Article
ISSN
2044-6055
Source
https://bmjopen.bmj.com/content/10/7/e037780.long
DOI
10.1136/bmjopen-2020-037780
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42981
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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