Diagnostic Accuracy of CCTA-derived Versus Angiography-derived Quantitative Flow Ratio (CAREER) Study: a Prospective Study Protocol

Overview

Journal BMJ Open

Specialty General Medicine

Date 2022 Jun 23

PMID 35738652

Authors

Tingwen Weng

Qian Gan

Zehang Li

Shaofeng Guan

Wenzheng Han

Xinrong Zhai

Ming Li

Lin Qi

Cheng Li

Yang Chen

Liang Zhang

Xifeng Chang

Shengxian Tu

Xinkai Qu

Affiliations

Soon will be listed here.

Abstract

Introduction: Coronary CT angiography (CCTA)-derived quantitative flow ratio (CT-QFR) is a novel non-invasive technology to assess the physiological significance of coronary stenoses, which enables fast and on-site computation of fractional flow reserve (FFR) from CCTA images. The objective of this investigator-initiated, prospective, single-centre clinical trial is to evaluate the diagnostic performance of CT-QFR with respect to angiography-derived QFR, using FFR as the reference standard.

Methods And Analysis: A total of 216 patients who have at least one lesion with a diameter stenosis of 30%-90% in an artery with ≥2.0 mm reference diameter will be enrolled in the study. FFR will be measured during invasive coronary angiography. CT-QFR and QFR will be assessed in two independent core laboratories in a blinded fashion. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying haemodynamically significant coronary stenosis with FFR as the reference standard. The major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions.

Ethics And Dissemination: The study was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University (2020K192). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

Trial Registration Number: NCT04665817.

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