Chronic Coronary Syndrome Clinical Trial
— OPERATEOfficial title:
Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing
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).
Status | Recruiting |
Enrollment | 800 |
Est. completion date | March 2025 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 90 Years |
Eligibility | Inclusion criteria 1. SCP or equivalenta suggestive of CCS and clinically stability 2. No history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT) 3. Age =30 years 4. Willing and able to provide informed consent Exclusion criteria 1. Prior CIT within 1 year prior to randomization 2. Clinically instability (e.g. cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure) 3. Non-sinus rhythm 4. Concomitant participation in another clinical trial 5. Complex structural heart disease 6. Non-cardiac illness with life expectancy < 2 years 7. Allergy to iodinated contrast agent 8. Estimated glomerular filtration rate<60 ml/min/1.73m2 within 90 days 9. Body mass index >35kg/m2 10. Expressing a clear preference for undergoing CIT or not 11. Pregnancy |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chaoyang Hospital | Beijing | Beijing |
China | Hebei Petrochina Central Hospital | Lanfang | Hebei |
China | Tianjin Chest Hospital | Tianjin | |
China | Tianjin First Central Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Chest Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The health-related quality of life assessment (SAQ) | Seattle Angina Questionnaire | 1 year | |
Other | The health-related quality of life assessment (EQ-5D) | Visual-analogue scale of the European Quality of Life-5 Dimensions | 1 year | |
Primary | 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 | |
Secondary | MACE | All-cause death, myocardial infarction and hospitalization due to unstable angina. | 1 year | |
Secondary | All-cause death | Any death. | 1 year | |
Secondary | 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 | |
Secondary | Hospitalization due to unstable angina | An hospitalization event in which the final diagnosis was myocardial ischemia. | 1 year | |
Secondary | Exposure to radiation | All exposure to radiation related to CIT and other cardiovascular procedures. | 1 year | |
Secondary | Procedural complications | All procedural complications related to CIT and other cardiovascular procedures. | 1 year | |
Secondary | Cumulative proportion of patients receiving other CITs | 1 year | ||
Secondary | Cumulative proportion of patients receiving CR | 1 year | ||
Secondary | Cumulative proportion of patients who had alteration in OMT based on results of CCTA | Thtough the initial management, an average of 2-5 days | ||
Secondary | Proportion of normal CCTA | Through the initial management, an average of 2-5 days | ||
Secondary | Proportion of necessary CCTA | Through the initial management, an average of 2-5 days |
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