Evaluating strategies to reduce unnecessary heart imaging tests for stable chest pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The OPERATE trial aims to improve the evaluation of patients with stable chest pain suggestive of chronic coronary syndrome by comparing two diagnostic strategies based on current guidelines. This multicenter, randomized controlled trial will include 800 subjects who will be assigned to either the NICE or ESC strategy to determine which approach better identifies low-risk patients who may not benefit from coronary computed tomography angiography (CCTA). The primary goal is to assess the rates of CCTA without obstructive coronary artery disease (CAD) and to evaluate the safety of both strategies over a one-year follow-up period. By optimizing diagnostic strategies, the study seeks to minimize unnecessary imaging tests and improve patient management.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Chaoyang Hospital
  Beijing, Beijing Municipality, China Recruiting
• Hebei Petrochina Central Hospital
  Lanfang, Hebei, China Recruiting
• Tianjin First Central Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Tianjin Chest Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Jia Zhou, MD — Tianjin Chest Hospital
• Study coordinator: Jia Zhou, MD
• Email: zhoujiawenzhang@126.com
• Phone: +8615522485560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.