Registry for identifying biomarkers in Takayasu's Arteritis

A Registry Study on Biomarkers of Takayasu's Arteritis

This study is trying to find new markers in the blood that can help doctors diagnose and track the disease activity in people with Takayasu's arteritis.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT03372980 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify new biomarkers for diagnosing and monitoring disease activity in patients with Takayasu's arteritis, a rare chronic vasculitis primarily affecting young Asian women. The study will utilize various methods to analyze patient data and improve understanding of the disease mechanism, which often remains undetected until significant vascular occlusion occurs. By focusing on patients who meet specific classification criteria, the study seeks to enhance diagnostic accuracy and disease management.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Takayasu's arteritis who meet the American College of Rheumatology classification criteria.

Not a fit: Patients with arteriographic lesions solely due to atherosclerosis or those suffering from other autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tools and monitoring strategies for patients with Takayasu's arteritis.

How similar studies have performed: While the study focuses on a rare condition, similar approaches in identifying biomarkers for other autoimmune diseases have shown promise, indicating potential for success.

Eligibility criteria

Retrospective

Inclusion Criteria:

Subjects who met the American College of Rheumatology 1990 classification criteria for Takayasu arteritis:

1. Age of onset ≤40 years,
2. Claudication of upper or lower extremities,
3. Decreased pulsation of 1 or both brachial arteries,
4. Difference of ≥ 10 mmHg in systolic blood pressure between arms,
5. Bruit over subclavian arteries or aorta,
6. \*Arteriographic evidence showing a branch of the aorta stenosis or occlusion.

Meeting more than 3 of 6 criteria suggests the diagnosis of Takayasu arteritis.

\*Angiography in this study was replaced by vascular magnetic resonance angiography(MRA)or computed tomography angiography(CTA).

Exclusion Criteria:

1. Arteriographic lesions that could be entirely due to atherosclerosis,
2. Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.) besides Takayasu arteritis,
3. Cogan's syndrome,
4. Behcet's disease,
5. Subjects with any serious acute or chronic infection,
6. Giant cell arteritis (large vessel vasculitis and at least 50 years old) or other infectious forms of large vessel vasculitis.

Prospective

Inclusion Criteria:

Subjects with initial suspicion of having Takayasu arteritis or patients with Takayasu arteritis need assessment of disease activity were prospectively enrolled.

Exclusion Criteria:

1. Patients without image studies.
2. Patients with confirmed other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.)

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yuan WANG, PhD

Conditions Takayasu's Arteritis; Biomarkers