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

Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing

This study is testing two different ways to see if they can help doctors better identify patients with stable chest pain who don’t need unnecessary heart imaging tests.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 30 Years to 90 Years
• Sex: All
• Sponsor: Tianjin Chest Hospital (other)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT05640752 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 30 and older with stable chest pain suggestive of chronic coronary syndrome and no history of coronary artery disease.

Not a fit: Patients with a history of coronary artery disease, clinically unstable conditions, or those who have undergone cardiac imaging within the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate identification of low-risk patients, reducing unnecessary imaging tests and associated healthcare costs.

How similar studies have performed: Previous studies have explored similar diagnostic strategies, but this trial aims to provide prospective data on their effectiveness in clinical practice.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 3 other locations

• 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

Conditions: Chronic Coronary Syndrome, Stable Chest Pain, Pretest Probability, Coronary Computed Tomography Angiography, Diagnostic Strategy, Coronary Artery Disease