NCT05640752Recruiting
Optimal Evaluation to Reduce Cardiovascular Imaging Testing
Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing
Source: ClinicalTrials.gov · Last updated 24 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 27 Nov 2022
- Start date
- 11 Dec 2023
- Primary completion date
- 11 Dec 2024
- Lead sponsor
- Tianjin Chest Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05640752
What you commit to
- Study type: Interventional
- Planned participants: 800
- From 11 Dec 2023 to the primary completion date, 11 Dec 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CIT within 1 year prior to randomization
- Concomitant participation in another clinical trial
Other illness
- Clinically instability (e.g. cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure)
- Complex structural heart disease
- Allergy to iodinated contrast agent
Age
- Non-cardiac illness with life expectancy \< 2 years
Other
- Non-sinus rhythm
- Estimated glomerular filtration rate\<60 ml/min/1.73m2 within 90 days
- Body mass index \>35kg/m2
- Expressing a clear preference for undergoing CIT or not
- Pregnancy
Who the study is looking for
- SCP or equivalenta suggestive of CCS and clinically stability
- No history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT)
- Age ≥30 years
- Willing and able to provide informed consent
Age in the registry: 30 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing ChaoYang Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hebei Petrochina Central Hospital Coordinator of this site? Confirm its status | Lanfang | China | Recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Tianjin First Central Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.