Clinical Features, Current Treatment and Clinical Outcomes in Patients With Inflammation-associated Non-rapidly-progressive Coronary Artery Disease (INR-CAD): a Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Behavioral
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Received, or are receiving, or will receive the 24-month clinical follow-up defined by the clinical follow-up protocol for INR-CAD.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhenyu Liu, M.D.
Pumch_lzy@163.com
+861069155068
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
INR-CAD Group
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov