Optimal Evaluation to Reduce Cardiovascular Imaging Testing
RecruitingNot applicableNCT05640752
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing
- Conditions
- Chronic Coronary Syndrome
- Interventions
- Diagnostic test: 2019 ESC guideline-determined diagnostic strategy
- Diagnostic test: 2016 NICE guideline-determined diagnostic strategy
- Sponsor
- Tianjin Chest Hospital
- Start date
- 2023-12-11
- Primary completion
- 2024-12-11
- Sex
- All
- Age range
- from 30 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05640752