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Recruiting
NCT05640752
Optimal Evaluation to Reduce Imaging Testing
Conditions: Chronic Coronary Syndrome
Sex: All
Ages: 30 Years – 90 Years
Phase: NA
Enrollment: 800
Sponsor: Tianjin Chest Hospital
Location: China
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).
Eligibility Criteria
Inclusion criteriaSCP or equivalenta suggestive of CCS and clinically stabilityNo history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT)Age ≥30 yearsWilling and able to provide informed consentExclusion criteriaPrior CIT within 1 year prior to randomizationClinically instability (e.g.
cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure)Non-sinus rhythmConcomitant participation in another clinical trialComplex structural heart diseaseNon-cardiac illness with life expectancy < 2 yearsAllergy to iodinated contrast agentEstimated glomerular filtration rate<60 ml/min/1.73m2
within 90 daysBody mass index >35kg/m2Expressing a clear preference for undergoing CIT or notPregnancy
Source: ClinicalTrials.gov (NCT05640752). StuddyBuddy aggregates publicly available trial information.