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

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Brief Title

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

Official Title

A Registry Study on Biomarkers of Takayasu's Arteritis

Brief Summary

      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.
    



Study Type

Observational


Primary Outcome

Diagnosis of each participant


Condition

Takayasu's Arteritis


Study Arms / Comparison Groups

 Case
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1000

Start Date

January 2016

Completion Date

January 2021

Primary Completion Date

January 2021

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.)
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 86-010-64456169, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03372980

Organization ID

ARSBTA


Responsible Party

Sponsor

Study Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Collaborators

 Shanghai Zhongshan Hospital

Study Sponsor

, , 


Verification Date

July 2020