Clinical Trial

Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Study acronym: OPERATE
Recruiting
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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).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-12-05; most recent amendment 2024-12-20.
Status change: Not Yet Recruiting → Recruiting 2023-01-13
Trial Details
NCT Number NCT05640752
Lead Sponsor Tianjin Chest Hospital
Conditions Chronic Coronary Syndrome
Enrollment 800 participants
Start Date 2023-12-11
Primary Completion 2024-12-11 (estimated)
Study Completion 2025-12-11 (estimated)
Updated on ClinicalTrials.gov 2024-12-24