Actively Recruiting
Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study
Led by Peking Union Medical College Hospital · Updated on 2025-11-19
39
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.
CONDITIONS
Official Title
Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, male or female
- Negative urine or blood pregnancy test for females with childbearing potential
- Prior history of coronary revascularization (PCI or CABG)
- Receiving standard treatment for secondary prevention of atherosclerotic coronary artery disease after last revascularization
- Hospitalized due to rapidly-progressive myocardial ischemia with typical angina symptoms and non-invasive evidence within 6 months or on immunosuppressive therapy within 12 months of last revascularization
- Angiographic evidence of new coronary lesions related to myocardial ischemia after last revascularization
- Evidence of inflammation demonstrated by elevated markers, diagnosis of systemic autoimmune disease or vasculitis, or receiving immunosuppressive therapy
- Receiving comprehensive treatment including ischemia-driven PCI performed no earlier than 40 days after starting immunosuppressive therapy
You will not qualify if you...
- Coronary restenosis caused by mechanical factors like stent under-expansion or rupture
- Other moderate to severe heart diseases such as congenital heart disease, valvular disease, myocarditis, cardiomyopathy, pericardial disease, pulmonary hypertension, heart failure, or arrhythmia
- Active acute or chronic infection including HIV or tuberculosis
- Active malignancy diagnosed within 12 months or requiring ongoing treatment
- Vital organ failure
- Life expectancy less than 1 year
- Contraindications or intolerance to secondary prevention treatments, contrast agents, glucocorticoids, or immunosuppressive agents
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Risk of non-compliance such as history of drug addiction or alcohol abuse
- Prior enrollment in this study
- Participation in another study within 30 days
- Involvement in planning or conducting this study
- Any condition deemed unsuitable by investigators for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhenyu Liu, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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