A Registry Study on Biomarkers of Takayasu's Arteritis (ARSBTA)

Official title

A Registry Study on Biomarkers of Takayasu's Arteritis

Overview

Takayasu arteritis is a chronic vasculitis mainly involving the aorta and its main branches such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as the coronary and pulmonary arteries. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. However, there is a considerable lack of understanding of the disease mechanism of Takayasu arteritis. Initially, the disease remains clinically silent (or remains undetected) until the patients present with vascular occlusion. Additionally, many individuals with Takayasu arteritis, however, have no apparent symptoms despite disease activity. Therefore, biomarkers for diagnosis and monitor disease activity in individuals with Takayasu arteritis are needed. In this study, the investigators therefore to use different methods to identify new biomarkers for diagnosing or monitoring the disease activity in individuals with Takayasu arteritis. These biomarkers may provide valuable insights into the underlying biochemical processes and aid the understanding of the pathophysiology of this disease.

Primary outcome measures

• Diagnosis of each participant [Time frame: These data is collected from the cases' medical record in an average of 3 month after the sample recruiting.]
• Disease activity of each participant [Time frame: These data is collected from the cases' medical record or during follow-up visit in an average of 6 month after the sample recruiting.]

Eligibility criteria

Retrospective

Inclusion criteria

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

• Age of onset ≤40 years,
• Claudication of upper or lower extremities,
• Decreased pulsation of 1 or both brachial arteries,
• Difference of ≥ 10 mmHg in systolic blood pressure between arms,
• Bruit over subclavian arteries or aorta,
• \*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

• Arteriographic lesions that could be entirely due to atherosclerosis,
• Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.) besides Takayasu arteritis,
• Cogan's syndrome,
• Behcet's disease,
• Subjects with any serious acute or chronic infection,
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT03372980 · ARSBTA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗