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Optimal Evaluation to Reduce Cardiovascular Imaging Testing

RECRUITINGN/ASponsored by Tianjin Chest Hospital
Actively Recruiting
PhaseN/A
SponsorTianjin Chest Hospital
Started2023-12-11
Est. completion2024-12-11
Eligibility
Age30 Years – 90 Years
Healthy vol.Accepted

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

Age: 30 Years – 90 YearsHealthy volunteers accepted
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

Conditions2

Chronic Coronary SyndromeHeart Disease

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