2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes.
Juhani Knuuti, William Wijns, Antti Saraste...
https://pubmed.ncbi.nlm.nih.gov/31504439Actively Recruiting
Age: 18Years +
All Genders
ID05860400
Efficacy and Safety of Comprehensive Treatment in Patients With Inflammation-associated Rapidly-progressive Coronary Artery Disease (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
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 rapidly-progressive coronary artery disease (IR-CAD), which differs from typical atherosclerotic coronary artery disease. This type progresses quickly, recurs often, and responds poorly to standard treatments after procedures like percutaneous coronary intervention (PCI). The study aims to evaluate the effectiveness and safety of a comprehensive treatment approach in patients with IR-CAD by comparing their health outcomes before and after receiving the treatment. The comprehensive treatment includes intensified secondary prevention for atherosclerotic coronary artery disease, immunosuppressive therapy using glucocorticoids and other agents, coronary revascularization procedures such as PCI or coronary artery bypass graft (CABG), supportive therapies to manage side effects, and lifestyle changes like a healthy diet, regular exercise, and quitting smoking. Patients receive this treatment and are followed for 24 months to assess its impact. Participants will be monitored through various assessments including major adverse cardiovascular events (MACE), target vessel related MACE, exercise capacity tests like walking distance and squats, coronary lesion imaging, and inflammation markers such as erythrocyte sedimentation rate and C-reactive protein. Safety is also tracked by monitoring major bleeding and severe infection events. The study compares these outcomes before treatment initiation and up to 24 months after comprehensive treatment starts.
CONDITIONS
Brief Title
Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study
Who Can Participate
Age: 18Years +
All Genders
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 the last revascularization.
- Hospitalized due to rapidly-progressive myocardial ischemia with typical angina symptoms and non-invasive evidence.
- Angiographic evidence of new coronary lesions related to myocardial ischemia after last revascularization.
- Evidence of inflammation shown by elevated markers, diagnosis of autoimmune or vasculitis diseases, 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 such as stent problems.
- Moderate to severe other heart diseases including congenital, valvular, myocarditis, cardiomyopathy, pericardial, pulmonary hypertension, heart failure, or arrhythmia.
- Active acute or chronic infection such as HIV or tuberculosis.
- Active malignancy diagnosed within 12 months or 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 intention to become pregnant during the study.
- Risk of non-compliance like history of drug addiction or alcohol abuse.
- Previous enrollment in this study.
- Participation in another study within 30 days.
- Involvement in planning or conducting this study.
- Any condition judged by investigators as unsuitable for participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring Before Treatment
Duration - Variable time before treatment initiation
Participants are observed before starting comprehensive treatment, including evaluation of coronary artery disease progression and inflammation markers.
Visits occur according to clinical needs before starting comprehensive treatment
Comprehensive Treatment
Duration - Up to 24 months
Participants receive comprehensive treatment including intensified secondary prevention, immunosuppressive therapy, coronary revascularization, and supportive therapies.
Visits scheduled regularly for treatment and assessment during the 24-month treatment period
Follow-up Monitoring After Treatment Initiation
Duration - Up to 24 months
Participants are monitored for major adverse cardiovascular events and safety outcomes after starting comprehensive treatment.
Regular follow-up visits throughout the 24-month period after treatment starts
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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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
2
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Bradley Tucker, Kaivan Vaidya, Blake J Cochran...
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https://pubmed.ncbi.nlm.nih.gov/30358832Residual Inflammatory Risk in Patients With Low LDL Cholesterol Levels Undergoing Percutaneous Coronary Intervention.
Paul Guedeney, Bimmer E Claessen, Deborah N Kalkman...
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