Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a Cohort Study (NCT06845410) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a Cohort Study
China120 participantsStarted 2025-04-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. 18 years of age or older, male or female.
ā. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
ā. Meeting the clinical diagnostic criteria for INR-CAD, including: (1) Angiographic evidence of coronary lesions (ā„ 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 \[TNF-Ī±\], et al; at least twice, ā„ 12 weeks apart), or (B) Positive autoantibodies (at least twice, ā„ 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).
ā. 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.
ā. Received, or are receiving, or will receive the 24-month clinical follow-up defined by the clinical follow-up protocol for INR-CAD.
Exclusion criteria
ā. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
What they're measuring
1
Major adverse cardiovascular events (MACE)
Timeframe: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.