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, 2020 07 20.
Article
em En
| MEDLINE
| ID: mdl-32690748
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 ANDANALYSIS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doença da Artéria Coronariana
/
Estenose Coronária
/
Reserva Fracionada de Fluxo Miocárdico
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Aspecto:
Ethics
/
Patient_preference
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2020
Tipo de documento:
Article