Trials
Search / Trial NCT05640752

Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Launched by TIANJIN CHEST HOSPITAL · Dec 5, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Stable Chest Pain Pretest Probability Coronary Computed Tomography Angiography Diagnostic Strategy Coronary Artery Disease

ClinConnect Summary

The OPERATE study is a clinical trial designed to find better ways to evaluate patients with stable chest pain that might be related to chronic coronary syndrome (CCS). This trial will compare two different strategies to help doctors identify patients who are at low risk and may not need further heart imaging tests, specifically coronary computed tomography angiography (CCTA). By doing this, the study aims to reduce unnecessary tests and focus on what is best for the patient's health.

To participate in this trial, individuals should be at least 30 years old and experiencing stable chest pain suggestive of CCS, without a history of coronary artery disease. Participants will be randomly assigned to one of the two diagnostic strategies being studied and will have regular follow-ups during the trial. It’s important to note that those with certain medical conditions, recent heart tests, or specific health issues may not be eligible. This study is currently recruiting participants, and it offers an opportunity to contribute to improving heart health evaluations in everyday medical practice.

Gender

ALL

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

Trial Officials

Jia Zhou, MD

Principal Investigator

Tianjin Chest Hospital

About Tianjin Chest Hospital

Tianjin Chest Hospital is a leading medical institution in China, specializing in respiratory diseases and thoracic surgery. With a strong commitment to advancing healthcare through research and innovation, the hospital conducts clinical trials aimed at improving patient outcomes and developing new treatment modalities. Equipped with state-of-the-art facilities and a dedicated team of healthcare professionals, Tianjin Chest Hospital plays a pivotal role in translating clinical research into practice, fostering collaboration between academia and industry to enhance therapeutic options for patients with respiratory conditions.

Locations

Beijing, Beijing, China

Tianjin, , China

Tianjin, Tianjin, China

Lanfang, Hebei, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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