Optimal Evaluation to Reduce Cardiovascular Imaging Testing
Recruiting now · Not applicable
Conditions studied: Chronic Coronary Syndrome
In brief
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).
Key facts
- Study ID
- NCT05640752
- Run by
- Tianjin Chest Hospital
- People needed
- 800
- Starts
- 2023-12-11
- Expected to finish
- 2025-12-11
- Last updated by the study team
- 2024-12-24
Who can join
Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- SCP or equivalenta suggestive of CCS and clinically stability
- No history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT)
- Age ≥30 years
- Willing and able to provide informed consent
You may not qualify if…
- Prior CIT within 1 year prior to randomization
- Clinically instability (e.g. cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure)
- Non-sinus rhythm
- Concomitant participation in another clinical trial
- Complex structural heart disease
- Non-cardiac illness with life expectancy < 2 years
- Allergy to iodinated contrast agent
- Estimated glomerular filtration rate<60 ml/min/1.73m2 within 90 days
- Body mass index >35kg/m2
- Expressing a clear preference for undergoing CIT or not
- Pregnancy
Where it is running
- Beijing Chaoyang Hospital — Beijing, Beijing Municipality, China (enrolling)
- Hebei Petrochina Central Hospital — Lanfang, Hebei, China (enrolling)
- Tianjin First Central Hospital — Tianjin, Tianjin Municipality, China (enrolling)
- Tianjin Chest Hospital — Tianjin, China (enrolling)
Full record on ClinicalTrials.gov
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