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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Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 01/07/2020
- Éditeur
- BMJ
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Seoul National University Bundang Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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SNUH SMG-SNU Boramae Medical Center pays non établi dans la noticeÉtablissement de santé
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Inha University Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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Keimyung University Dongsan Medical Center Department of Medicine pays non établi dans la noticeÉtablissement de santé
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Keimyung University pays non établi dans la noticeUniversité ou école supérieure
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Ewha Womans University Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
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Inje University Ilsan Paik Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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Inje University Sanggye Paik Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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Chungbuk National University pays non établi dans la noticeUniversité ou école supérieure
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Seoul Metropolitan Boramae Hospital Department of Internal Medicine pays non établi dans la noticeÉtablissement de santé
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College of Medicine Department of Internal Medicine pays non établi dans la noticeUniversité ou école supérieure
Department of Internal Medicine — Seoul National University Bundang Hospital, SNUH SMG-SNU Boramae Medical Center et Department of Internal Medicine — Inha University Hospital, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.