About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV) and non-invasive evidence of myocardial ischemia; and
Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
Occurred after the last coronary revascularization; and
Related to myocardial ischemia (location, extent, severity, et al).
Disqualifiers
Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
Active acute or chronic infection (human immunodeficiency virus [HIV], tuberculosis, et al).
Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
Trial population
All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after January 1, 2022 will be screened for study participation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Healthy life style
BehavioralHealthy diet, regular exercise, and quitting smoking
Secondary prevention for atherosclerotic coronary artery disease
DrugAntiplatelet therapy, as well as medications for control of heart rate, blood pressure, low-density lipoprotein cholesterol, and blood glucose
Immunosuppressive therapy
DrugGlucocorticoids and/or immunosuppressive agents
Coronary revascularization
Procedure/SurgeryPercutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
Supportive therapies
DrugMedical interventions for prevention and treatment of the side effects of the above treatment, such as abnormal liver function, hypocalcemia, hypokalemia, peptic ulcer, infection, et al.
Treatment groups
Trial outcomes
Primary outcomes
Major adverse cardiovascular events (MACE)
The composite endpoint including death, or Q wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
Secondary outcomes
Target vessel related major adverse cardiovascular events (TV-MACE)
The composite endpoint including cardiovascular death, or target vessel related Q wave myocardial infarction, or target vessel related unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or target vessel related unplanned myocardial ischemia-driven hospitalization.
Death
All-cause death.
Myocardial infarction
Myocardial injury due to myocardial ischemia.
Target vessel related myocardial infarction
Myocardial infarction in the area supplied by the target vessel.
Other outcomes
Major bleeding events
Major bleeding events evaluated according to the Bleeding Academic Research Consortium (BARC) criteria.
Severe infection events
Infection events involving vital organs, or with complications (such as structural change and/or dysfunction of vital organs, septic shock), or requiring hospitalization, or requiring treatment with intravenous antibiotics, or requiring treatment with interventional procedures or surgeries.
Sponsors and contacts
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