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Published in: BMC Cardiovascular Disorders 1/2023

Open Access 01-12-2023 | CT Angiography | Study Protocol

Comparison of two diagnostic strategies for patients with stable chest pain suggestive of chronic coronary syndrome: rationale and design of the double-blind, pragmatic, randomized and controlled OPERATE Trial

Authors: Jia Zhou, Ting Xin, Yahang Tan, Jianzhong Pang, Tao Chen, Hao Wang, Jia Zhao, Chang Liu, Cun Xie, Minghui Wang, Chengjian Wang, Yuanying Liu, Jie Zhang, Yankun Liu, Chen Shanfu, Chunjie Li, Hongliang Cong

Published in: BMC Cardiovascular Disorders | Issue 1/2023

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Abstract

Background

To achieve potential financial savings and avoid exposing the patients to unnecessary risk, an optimal diagnostic strategy to identify low risk individual who may derive minimal benefit from further cardiac imaging testing (CIT) is important for patients with stable chest pain (SCP) suggestive of chronic coronary syndrome (CCS). Although several diagnostic strategies have been recommended by the most recent guidelines, few randomized controlled trials (RCTs) have prospectively investigated the actual effect of applying these strategies in clinical practice.

Methods

OPERATE (OPtimal Evaluation of stable chest pain to Reduce unnecessAry utilization of cardiac imaging TEsting) trial is an investigator-initiated, multicenter, coronary computed tomography angiography (CCTA)-based, 2-arm parallel-group, double-blind, pragmatic and confirmative RCT planning to include 800 subjects with SCP suggestive of CCS. After enrollment, all subjects will be randomized to two arms (2016 U.K. National Institute of Health and Care Excellence guideline-determined and 2019 European Society of Cardiology guideline-determined diagnostic strategy) on a 1:1 basis. According to each strategy, CCTA should be referred and deferred for a subject in high and low risk group, respectively. The primary (effectiveness) endpoint is CCTA without obstructive coronary artery disease. Safety of each strategy will be mainly assessed by 1-year major adverse cardiovascular event rates.

Discussion

The OPERATE trial will provide comparative effectiveness and safety evidences for two different diagnostic strategies for patients with SCP suggestive of CCS, with the intension of improving the diagnostic yield of CCTA at no expense of safety.

Clinical trial registration

ClinicalTrial.org Identifier NCT05640752.
Appendix
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Metadata
Title
Comparison of two diagnostic strategies for patients with stable chest pain suggestive of chronic coronary syndrome: rationale and design of the double-blind, pragmatic, randomized and controlled OPERATE Trial
Authors
Jia Zhou
Ting Xin
Yahang Tan
Jianzhong Pang
Tao Chen
Hao Wang
Jia Zhao
Chang Liu
Cun Xie
Minghui Wang
Chengjian Wang
Yuanying Liu
Jie Zhang
Yankun Liu
Chen Shanfu
Chunjie Li
Hongliang Cong
Publication date
01-12-2023
Publisher
BioMed Central
Keyword
CT Angiography
Published in
BMC Cardiovascular Disorders / Issue 1/2023
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-023-03424-3

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