NCT05640752 Optimal Evaluation to Reduce Cardiovascular Imaging Testing
| NCT ID | NCT05640752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Chest Hospital |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2024-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2023-12-11 with a primary completion date of 2024-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jia Zhou, MD
PRINCIPAL INVESTIGATOR
Tianjin Chest Hospital
Frequently Asked Questions
Who can join the NCT05640752 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 90 Years, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05640752 currently recruiting?
Yes, NCT05640752 is actively recruiting participants. Contact the research team at zhoujiawenzhang@126.com for enrollment information.
Where is the NCT05640752 trial being conducted?
This trial is being conducted at Beijing, China, Lanfang, China, Tianjin, China, Tianjin, China.
Who is sponsoring the NCT05640752 clinical trial?
NCT05640752 is sponsored by Tianjin Chest Hospital. The principal investigator is Jia Zhou, MD at Tianjin Chest Hospital. The trial plans to enroll 800 participants.