Actively Recruiting
Clinical Features, Current Treatment and Clinical Outcomes in Patients With Inflammation-associated Non-rapidly-progressive Coronary Artery Disease (INR-CAD): a Cohort Study
Led by Peking Union Medical College Hospital · Updated on 2025-11-19
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a special type of coronary artery disease called inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD). This condition differs from typical atherosclerotic coronary artery disease by affecting mainly women, starting earlier in life, lacking traditional risk factors, showing signs of chronic inflammation, and responding differently to treatments. The study aims to understand the clinical features, current treatments, and outcomes in patients with INR-CAD through an observational cohort design. Patients diagnosed with INR-CAD are identified based on specific clinical criteria including coronary artery lesions and evidence of chronic inflammation. They receive follow-up care over 24 months according to a protocol designed for INR-CAD. Treatments under evaluation include healthy lifestyle changes, secondary prevention medications for atherosclerosis, immunosuppressive therapy, coronary revascularization procedures like PCI or CABG, and supportive therapies to manage side effects. Participants will undergo various assessments during the 24-month follow-up, including monitoring for major adverse cardiovascular events (MACE) such as heart attacks and hospitalizations. Researchers will also measure exercise capacity, detailed angiographic features of coronary lesions, and inflammatory markers like ESR, hs-CRP, IL-6, and TNF-alpha. Safety outcomes like major bleeding and severe infections will be tracked. The study will compare outcomes between patients with different diagnoses and treatments to better understand INR-CAD's progression and management.
CONDITIONS
Brief Title
Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a 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.
- Angiographic evidence of coronary lesions with 50% or more diameter narrowing.
- Evidence of chronic inflammation within 24 months, including positive inflammatory markers, autoantibodies, diagnosis of chronic inflammatory diseases, or use of immunosuppressive therapy.
- Does not meet criteria for rapidly-progressive inflammation-associated coronary artery disease (IR-CAD).
- Received, receiving, or planned to receive a 24-month clinical follow-up for INR-CAD.
You will not qualify if you...
- Moderate to severe other heart diseases like congenital heart disease, valvular disease, myocarditis, cardiomyopathy, pericardial disease, pulmonary hypertension, heart failure, or arrhythmia.
- Active cancer diagnosed within the past 12 months or needing ongoing treatment.
- Failure of vital organs.
- Life expectancy less than 1 year.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- History of drug addiction or alcohol abuse that may affect compliance.
- Previous enrollment in this study.
- Participation in another study within 30 days.
- Involvement in planning or conducting this study.
- Any condition judged by investigators to make participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants clinically diagnosed with INR-CAD are observed during a 24-month clinical follow-up to assess clinical features, treatment, and outcomes.
Regular clinical follow-up visits over 24 months according to protocol
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.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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