Optimal Evaluation to Reduce Cardiovascular Imaging Testing
Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing
Tianjin Chest Hospital
800 participants
Dec 11, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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
Exclusion Criteria11
- 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
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Interventions
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.
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.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05640752