Actively Recruiting
Optimal Evaluation to Reduce Cardiovascular Imaging Testing
Led by Tianjin Chest Hospital · Updated on 2024-12-24
800
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Optimal Evaluation to Reduce Cardiovascular Imaging Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable or new-onset chest pain suggestive of chronic coronary syndrome and clinically stable
- No history of coronary artery disease, including prior myocardial infarction, coronary revascularization, or documented CAD by previous cardiac imaging
- Age 30 years or older
- Willing and able to provide informed consent
You will not qualify if you...
- Cardiac imaging test within the past year before randomization
- Clinical instability such as cardiogenic shock, acute coronary syndrome, severe arrhythmias, or NYHA class III or IV heart failure
- Non-sinus heart rhythm
- Participation in another clinical trial
- Complex structural heart disease
- Non-cardiac illness with life expectancy less than 2 years
- Allergy to iodinated contrast agents
- Estimated glomerular filtration rate below 60 ml/min/1.73m2 within 90 days
- Body mass index over 35 kg/m2
- Clear preference for or against undergoing cardiac imaging testing
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Hebei Petrochina Central Hospital
Lanfang, Hebei, China
Actively Recruiting
3
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
4
Tianjin Chest Hospital
Tianjin, China, 300000
Actively Recruiting
Research Team
J
Jia Zhou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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