An interventional study of 2019 ESC guideline-determined diagnostic strategy and 2016 NICE guideline-determined diagnostic strategy in Chronic Coronary Syndrome, sponsored by Tianjin Chest Hospital. Recruiting at 4 sites in China. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Tianjin Chest Hospital · Not applicable, Interventional, and Diagnostic
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.
Exclusion criteria
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.
Diagnostic Test: 2019 ESC guideline-determined diagnostic strategy
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.
Diagnostic Test: 2016 NICE guideline-determined diagnostic strategy
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.
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.
CCTA without obstructive CAD
The summary of nonobstructive CAD, no sign of CAD and nondiagnostic result detected by CCTA according to each strategy
Time frame: Through the initial management, an average of 2-5 days
MACE
All-cause death, myocardial infarction and hospitalization due to unstable angina.
Time frame: 1 year
All-cause death
Any death.
Time frame: 1 year
Myocardial infarction
Myocardial infarction was defined and classified as spontaneous or coronary procedure-related MI according to the Fourth Universal Definition of Myocardial Infarction.
Time frame: 1 year
Hospitalization due to unstable angina
An hospitalization event in which the final diagnosis was myocardial ischemia.
Time frame: 1 year
Exposure to radiation
All exposure to radiation related to CIT and other cardiovascular procedures.
Time frame: 1 year
Procedural complications
All procedural complications related to CIT and other cardiovascular procedures.
Time frame: 1 year
Cumulative proportion of patients receiving other CITs
Time frame: 1 year
Cumulative proportion of patients receiving CR
Time frame: 1 year
Cumulative proportion of patients who had alteration in OMT based on results of CCTA
Time frame: Thtough the initial management, an average of 2-5 days
Proportion of normal CCTA
Time frame: Through the initial management, an average of 2-5 days
Proportion of necessary CCTA
Time frame: Through the initial management, an average of 2-5 days
The health-related quality of life assessment (SAQ)
Seattle Angina Questionnaire
Time frame: 1 year
The health-related quality of life assessment (EQ-5D)
Visual-analogue scale of the European Quality of Life-5 Dimensions
Time frame: 1 year
Plan to share: No
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Tianjin Chest Hospital