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
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Published:2023-08-23
Issue:1
Volume:23
Page:
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ISSN:1471-2261
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Container-title:BMC Cardiovascular Disorders
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language:en
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Short-container-title:BMC Cardiovasc Disord
Author:
Zhou Jia,Xin Ting,Tan Yahang,Pang Jianzhong,Chen Tao,Wang Hao,Zhao Jia,Liu Chang,Xie Cun,Wang Minghui,Wang Chengjian,Liu Yuanying,Zhang Jie,Liu Yankun,Shanfu Chen,Li Chunjie,Cong Hongliang
Abstract
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.
Funder
National Natural Science Foundation of China Applied and Basic Research by Multi-input Foundation of Tianjin Tianjin Health Research Project Tianjin Key Laboratory of Cardiovascular Emergency and Critical Care certified by Tianjin Municipal Science and Technology Bureau Tianjin Medical Discipline Construction Project Youth Innovative Talents Training Program of Tianjin First Central Hospital Young Talents Tianjin Key Research Program of Traditional Chinese Medicine
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine
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