About this trial
This is a cohort study to investigate the clinical features, current treatment and clinical outcomes in patients with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older, male or female.
Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
Meeting the clinical diagnostic criteria for INR-CAD, including: (1) Angiographic evidence of coronary lesions (≥ 50% diameter stenosis, de novo or restenotic); (2) Evidence of chronic inflammation within 24 months: (A) Positive inflammatory markers (erythrocyte sedimentation rate [ESR], high-sensitivity C-reactive protein [hs-CRP], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α], et al; at least twice, ≥ 12 weeks apart), or (B) Positive autoantibodies (at least twice, ≥ 12 weeks apart), or (C) Established diagnosis of chronic inflammatory diseases (autoimmune disease, systemic vasculitis, psoriasis, tuberculosis, et al), or (D) Receiving immunosuppressive therapy (glucocorticoids, immunosuppressive agents, et al).
NOT meeting the clinical diagnostic criteria for IR-CAD, including: (1) Hospitalization due to myocardial ischemia, including: (A) Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV), and (B) Non-invasive evidence of myocardial ischemia; (2) Angiographic evidence of new or worsened coronary lesions (de novo or restenotic) considered relevant to myocardial ischemia, which occurred: (A) Within 6 months of last coronary angiography in any patients, or (B) Within 12 months of last coronary angiography in patients receiving immunosuppressive therapy within 24 months.
Disqualifiers
Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
Vital organ failure.
Life expectancy < 1 year.
Trial population
All patients who have been admitted to the Department of Cardiology, Peking Union Medical College Hospital (PUMCH) since 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
Death
All-cause death.
Q-wave myocardial infarction
Myocardial injury due to myocardial ischemia, resulting in newly formed pathological Q waves in ≥ 2 contiguous leads or equivalent manifestations on electrocardiogram.
Unplanned myocardial ischemia-driven coronary revascularization
Unplanned coronary revascularization (PCI or CABG) due to myocardial ischemia.
Unplanned myocardial ischemia-driven hospitalization
Unplanned hospitalization due to myocardial ischemia.
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, et al), or requiring hospitalization, or requiring treatment with intravenous antibiotics, or requiring treatment with interventional procedures or surgeries.
Sponsors and contacts
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