Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a Cohort Study

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a specific type of coronary artery disease that is linked to inflammation, called inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD). The goal is to learn more about the characteristics of this condition, the current treatments available, and the outcomes for patients. Researchers are looking for participants who are at least 18 years old and have certain signs of coronary artery problems along with evidence of chronic inflammation.

To be eligible, participants must not have severe heart diseases or active cancers and should not be pregnant or breastfeeding. Those who join the study can expect to be followed for 24 months as part of a structured clinical follow-up. This study is not yet recruiting, so it’s important to keep an eye out for when it begins if you or someone you know is interested in participating.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. 18 years of age or older, male or female.
• • 2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
• • 3. 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).
• • 4. 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.
• • 5. 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:
• • 1. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
• • 2. Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
• • 3. Vital organ failure.
• • 4. Life expectancy \< 1 year.
• • 5. In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
• • 6. Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
• • 7. Previous enrollment in this study.
• • 8. Participation in another study within 30 days.
• • 9. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
• • 10. Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.