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| ID | Type | Description | Link |
|---|---|---|---|
| 62206197 | Other Grant/Funding Number | National Natural Science Foundation of China | |
| TJWJ2022QN067 | Other Grant/Funding Number | Tianjin Health Research Project | |
| 21JCYBJC00820 | Other Grant/Funding Number | Applied and Basic Research by Multi-input Foundation of Tianjin |
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In daily clinical routine, the evaluation of new-onset and stable chest pain (SCP) suggestive of chronic coronary syndrome (CCS) remains a challenge for physicians. Although coronary computed tomography angiography (CCTA) seems to be the first-line cardiac imaging testing (CIT) according to the recommendations from current guidelines, the optimal diagnostic strategy to identify low risk patients who may derive minimal benefit from further CIT is the cornerstone of clinical management for SCP. Recently, different diagnostic strategies were provided to effectively defer unnecessary CIT, but few studies have prospectively determined the actual effect of applying these strategies in clinical practice. Therefore, the OPERATE study was designed to compare the effectiveness and safety of two proposed diagnostic strategies in identification of low risk individual who may derive minimal benefit from CCTA among patients with SCP suggestive of CCS in a pragmatic randomized controlled trial (RCT).
OPERATE trial was an investigator-initiated, multicenter, prospective, CCTA-based, 2-arm 1:1 parallel-group, double-blind and pragmatic RCT planned to include 800 subjects with SCP suggestive of CCS. Subjects were assigned randomly to two groups: 1) 2016 National Institutes for Clinical Excellence guidelines-determined diagnostic strategy (NICE strategy) and 2) 2019 European Society of Cardiology guidelines-determined diagnostic strategy (ESC strategy) The primary objective of OPERATE trial is to compare the rates of CCTA without obstructive CAD according to NICE and ESC strategy. The key secondary objective is to assess whether the two strategies have no significant difference in terms of major adverse cardiac events (MACE). The investigators hypothesize that when comparing with NICE strategy, ESC strategy which sequentially incorporated the ESC-PTP model with RF-CL model will decrease the probability of CCTA without obstructive CAD but not at the expense of safety and cost over a follow-up period of 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESC strategy | Experimental | ESC-PTP is calculated using age, sex and type of chest pain according to 2019 ESC guideline for the diagnosis and management of CCS and RF-CL is calculated using age, sex, type of chest pain, hypertension, dyslipidemia, diabetes, smoking and family history of CAD based on the publication of Winther et al., respectively. According to ESC strategy, subjects with ESC-PTP ≤5% are classified into low risk group and ones with ESC-PTP ≥15% are classified into high risk group. For subjects with ESC-PTP of 5%-15%, ones with RF-CL ≥15% are classified into high risk group and ones with RF-CL <15% are classified into low risk group. CCTA should be referred for a subject in high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA. |
|
| NICE strategy | Experimental | According to NICE strategy, subjects with nonanginal chest pain and normal ECG are classified into low risk group and ones with typical and atypical angina or nonanginal chest pain with abnormal ECG are classified into high risk group. CCTA should be referred for a subject in high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2019 ESC guideline-determined diagnostic strategy | Diagnostic Test | ESC-PTP is calculated using age, sex and type of chest pain according to 2019 ESC guideline for the diagnosis and management of CCS and RF-CL is calculated using age, sex, type of chest pain, hypertension, dyslipidemia, diabetes, smoking and family history of CAD based on the publication of Winther et al., respectively. According to ESC strategy, subjects with ESC-PTP ≤5% are classified into low risk group and ones with ESC-PTP ≥15% are classified into high risk group. For subjects with ESC-PTP of 5%-15%, ones with RF-CL ≥15% are classified into high risk group and ones with RF-CL <15% are classified into low risk group. CCTA should be referred for a subject in high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA. |
| Measure | Description | Time Frame |
|---|---|---|
| CCTA without obstructive CAD | The summary of nonobstructive CAD, no sign of CAD and nondiagnostic result detected by CCTA according to each strategy | Through the initial management, an average of 2-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | All-cause death, myocardial infarction and hospitalization due to unstable angina. | 1 year |
| All-cause death | Any death. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The health-related quality of life assessment (SAQ) | Seattle Angina Questionnaire | 1 year |
| The health-related quality of life assessment (EQ-5D) | Visual-analogue scale of the European Quality of Life-5 Dimensions |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Zhou, MD | Contact | +8615522485560 | zhoujiawenzhang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Zhou, MD | Tianjin Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37612631 | Derived | Zhou J, Xin T, Tan Y, Pang J, Chen T, Wang H, Zhao J, Liu C, Xie C, Wang M, Wang C, Liu Y, Zhang J, Liu Y, Shanfu C, Li C, Cong H. 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 Cardiovasc Disord. 2023 Aug 23;23(1):416. doi: 10.1186/s12872-023-03424-3. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 2016 NICE guideline-determined diagnostic strategy | Diagnostic Test | For subjects assigned to NICE strategy, ones with nonanginal chest pain and normal ECG were classified into low risk group and ones with typical and atypical angina or nonanginal chest pain with abnormal ECG were classified into high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA. |
|
| Myocardial infarction | Myocardial infarction was defined and classified as spontaneous or coronary procedure-related MI according to the Fourth Universal Definition of Myocardial Infarction. | 1 year |
| Hospitalization due to unstable angina | An hospitalization event in which the final diagnosis was myocardial ischemia. | 1 year |
| Exposure to radiation | All exposure to radiation related to CIT and other cardiovascular procedures. | 1 year |
| Procedural complications | All procedural complications related to CIT and other cardiovascular procedures. | 1 year |
| Cumulative proportion of patients receiving other CITs | 1 year |
| Cumulative proportion of patients receiving CR | 1 year |
| Cumulative proportion of patients who had alteration in OMT based on results of CCTA | Thtough the initial management, an average of 2-5 days |
| Proportion of normal CCTA | Through the initial management, an average of 2-5 days |
| Proportion of necessary CCTA | Through the initial management, an average of 2-5 days |
| 1 year |
| Hebei Petrochina Central Hospital | Recruiting | Lanfang | Hebei | China |
|
| Tianjin First Central Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| Tianjin Chest Hospital | Recruiting | Tianjin | 300000 | China |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |