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

BMC Cardiovascular Disorders

Study Protocol

Chang Liu¹  Hongliang Cong²  Jia Zhou²  Yahang Tan³  Jie Zhang⁴  Cun Xie⁴  Yuanying Liu⁴  Minghui Wang⁴  Jia Zhao⁴  Chengjian Wang⁴  Chunjie Li⁴  Ting Xin⁵  Yankun Liu⁶  Jianzhong Pang⁶  Chen Shanfu⁶  Hao Wang⁷  Tao Chen⁸ 

[1]Clinical School of Thoracic, Tianjin Medical University, Tianjin, China

[2]Clinical School of Thoracic, Tianjin Medical University, Tianjin, China

[3]Department of Cardiology, Tianjin Chest Hospital, Tianjin, China

[4]Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

[5]Department of Cardiology, Tianjin Chest Hospital, Tianjin, China

[6]Department of Cardiology, Tianjin First Central Hospital, Tianjin, China

[7]Department of Cardiology, Tianjin Second Teaching Hospital of Tianjin University of Traditional Chinese, Tianjin, China

[8]Department of Clinical Epidemiology and Evidence-Based Medicine, Friendship Hospital, Capital Medical University, Beijing, China

[9]Department of Emergency, Hebei Petrochina Central Hospital, Langfang, Hebei, China

关键词: Diagnostic strategy;    Cardiac imaging testing;    Stable chest pain;    Chronic coronary syndrome;    Randomized controlled trial;    Coronary computed tomography angiography;    Major adverse cardiovascular event;    Pretest probability;   

DOI  :  10.1186/s12872-023-03424-3

 received in 2023-07-07, accepted in 2023-08-01,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundTo 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.MethodsOPERATE (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.DiscussionThe 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 registrationClinicalTrial.org Identifier NCT05640752.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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