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Optimal Evaluation to Reduce Cardiovascular Imaging Testing

RecruitingNAAges 30 Years - 90 YearsAllTianjin Chest Hospital
NCT05640752 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
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
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What it tests

  • 2019 ESC guideline-determined diagnostic strategy
  • 2016 NICE guideline-determined diagnostic strategy
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Where

4 sites
Beijing Chaoyang Hospital
Beijing, China
Hebei Petrochina Central Hospital
Lanfang, China
Tianjin First Central Hospital
Tianjin, China
Tianjin Chest Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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