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
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 (S...
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| Language: | English |
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BMC
2023-08-01
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| Series: | BMC Cardiovascular Disorders |
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| Online Access: | https://doi.org/10.1186/s12872-023-03424-3 |
| _version_ | 1797578281823764480 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jia Zhou |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T22:20:39Z |
| format | Article |
| id | doaj.art-c8765672e9fd448c8f72ce1007db35df |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-03-10T22:20:39Z |
| publishDate | 2023-08-01 |
| publisher | BMC |
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| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-c8765672e9fd448c8f72ce1007db35df2023-11-19T12:18:39ZengBMCBMC Cardiovascular Disorders1471-22612023-08-0123111110.1186/s12872-023-03424-3Comparison 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 TrialJia Zhou0Ting Xin1Yahang Tan2Jianzhong Pang3Tao Chen4Hao Wang5Jia Zhao6Chang Liu7Cun Xie8Minghui Wang9Chengjian Wang10Yuanying Liu11Jie Zhang12Yankun Liu13Chen Shanfu14Chunjie Li15Hongliang Cong16Clinical School of Thoracic, Tianjin Medical UniversityDepartment of Cardiology, Tianjin First Central HospitalDepartment of Cardiology, Beijing Chaoyang Hospital, Capital Medical UniversityDepartment of Cardiology, Tianjin Second Teaching Hospital of Tianjin University of Traditional ChineseDepartment of Emergency, Hebei Petrochina Central HospitalDepartment of Clinical Epidemiology and Evidence-Based Medicine, Friendship Hospital, Capital Medical UniversityDepartment of Cardiology, Tianjin Chest HospitalClinical School of Thoracic, Tianjin Medical UniversityDepartment of Cardiology, Tianjin Chest HospitalDepartment of Cardiology, Tianjin Chest HospitalDepartment of Cardiology, Tianjin Chest HospitalDepartment of Cardiology, Tianjin Chest HospitalDepartment of Cardiology, Tianjin Chest HospitalDepartment of Cardiology, Tianjin Second Teaching Hospital of Tianjin University of Traditional ChineseDepartment of Cardiology, Tianjin Second Teaching Hospital of Tianjin University of Traditional ChineseDepartment of Cardiology, Tianjin Chest HospitalClinical School of Thoracic, Tianjin Medical UniversityAbstract 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.https://doi.org/10.1186/s12872-023-03424-3Diagnostic strategyCardiac imaging testingStable chest painChronic coronary syndromeRandomized controlled trialCoronary computed tomography angiography |
| spellingShingle | 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 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 Diagnostic strategy Cardiac imaging testing Stable chest pain Chronic coronary syndrome Randomized controlled trial Coronary computed tomography angiography |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Diagnostic strategy Cardiac imaging testing Stable chest pain Chronic coronary syndrome Randomized controlled trial Coronary computed tomography angiography |
| url | https://doi.org/10.1186/s12872-023-03424-3 |
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