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

Soo Hyun Kim, Si Hyuck Kang, Woo Young Chung, Chang Hwan Yoon, Sang Don Park, Chang Wook Nam, Ki Hwan Kwon, Joon Hyung Doh, Young Sup Byun, Jang Whan Bae, Tae Jin Youn, In Ho Chae

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish
Pages (from-to)e037780
JournalBMJ Open
Volume10
Issue number7
DOIs
StatePublished - 20 Jul 2020

Keywords

  • cardiovascular imaging
  • computed tomography
  • coronary heart disease

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