Chronic Coronary Syndrome
Conditions
Keywords
Stable Chest Pain, Pretest Probability, Coronary Computed Tomography Angiography, Diagnostic Strategy, Coronary Artery Disease
Brief summary
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).
Detailed description
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.
Interventions
DIAGNOSTIC_TEST2019 ESC 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.
DIAGNOSTIC_TEST2016 NICE guideline-determined diagnostic strategy
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.
Sponsors
Tianjin Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CCTA without obstructive CAD | Through the initial management, an average of 2-5 days | The summary of nonobstructive CAD, no sign of CAD and nondiagnostic result detected by CCTA according to each strategy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of necessary CCTA | Through the initial management, an average of 2-5 days | — |
| MACE | 1 year | All-cause death, myocardial infarction and hospitalization due to unstable angina. |
| All-cause death | 1 year | Any death. |
| Myocardial infarction | 1 year | Myocardial infarction was defined and classified as spontaneous or coronary procedure-related MI according to the Fourth Universal Definition of Myocardial Infarction. |
| Hospitalization due to unstable angina | 1 year | An hospitalization event in which the final diagnosis was myocardial ischemia. |
| Exposure to radiation | 1 year | All exposure to radiation related to CIT and other cardiovascular procedures. |
| 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 | — |
| Procedural complications | 1 year | All procedural complications related to CIT and other cardiovascular procedures. |
| Cumulative proportion of patients receiving other CITs | 1 year | — |
| Cumulative proportion of patients receiving CR | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| The health-related quality of life assessment (SAQ) | 1 year | Seattle Angina Questionnaire |
| The health-related quality of life assessment (EQ-5D) | 1 year | Visual-analogue scale of the European Quality of Life-5 Dimensions |
Countries
China
Contacts
Primary ContactJia Zhou, MD
Outcome results
None listed