Clinical features, treatments, and outcomes in inflammation-associated non-rapidly-progressive coronary artery disease

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

This study will see how current treatments, inflammation markers, and patient characteristics relate to outcomes in people with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06845410 on ClinicalTrials.gov

What this trial studies

A cohort of adults with INR-CAD will be enrolled at Peking Union Medical College Hospital and followed prospectively. Investigators will collect clinical histories, angiography results, serial inflammation markers or autoantibodies, treatment details (lifestyle measures, secondary prevention, immunosuppressive therapy, and revascularization), and clinical outcomes including disease progression, restenosis, and major cardiovascular events. Serial laboratory tests and imaging will be used to document progression and treatment response over time. The study aims to define the clinical phenotype of INR-CAD and identify treatment patterns associated with better or worse outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) with angiographic coronary lesions (≥50% stenosis) plus evidence of chronic inflammation or positive autoantibodies, or who are receiving immunosuppressive therapy, and who do not meet criteria for rapidly progressive disease are ideal candidates.

Not a fit: People with typical atherosclerotic CAD without inflammatory markers, or those with rapidly progressive IR-CAD, are unlikely to benefit from this study's specific findings.

Why it matters

Potential benefit: If successful, the findings could help clinicians recognize INR-CAD earlier and tailor treatments, including immunosuppression, to slow progression and improve outcomes.

How similar studies have performed: Some anti-inflammatory therapies have reduced cardiovascular events in other CAD populations (for example, CANTOS and COLCOT), but the INR-CAD classification and targeted management approach remain relatively novel and not widely tested.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhenyu Liu, M.D.

Conditions Coronary Artery Disease; Coronary Artery Disease Progression; Coronary Artery Stenosis; Coronary Artery Restenosis; Inflammation; Inflammatory Disease; Inflammation Vascular; Progression, Disease