NCT06845410 Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a Cohort Study
| NCT ID | NCT06845410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06845410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845410 currently recruiting?
Yes, NCT06845410 is actively recruiting participants. Contact the research team at Pumch_lzy@163.com for enrollment information.
Where is the NCT06845410 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06845410 clinical trial?
NCT06845410 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 120 participants.