China Takayasu Arteritis Registry (CTA Registry)

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Brief Title

China Takayasu Arteritis Registry (CTA Registry)

Official Title

China Takayasu Arteritis Registry (CTA Registry)

Brief Summary

      Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta
      and its major branches. The epidemiology and pathophysiology of TA is still unclear in China,
      although many studies have been done. Our previous study supporting by National Natural
      Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor
      necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were
      associated with TA in Chinese han population. Further investigations with larger samples are
      needed to fully understand the a pathophysiology of TA. The purpose of this study is to build
      a Chinese national registry system for TA to obtain real-world information, such as current
      status of characteristics, diagnosis, disease activity, the severity of disease, treatment
      and outcomes of Chinese TA patients. To analysis and development of effective disease
      monitoring and treatment strategies.
    

Detailed Description

      Takayasu arteritis (TA) is a chronic vasculitis that causes inflammation of the aorta and its
      main branches and is characterized by adventitial thickening and cellular infiltration of the
      tunica media, with local destruction of vascular smooth muscle cells and elastin. The disease
      is very rare but most commonly occurs in China. In the last decade, the results of our study
      indicated that HLA-DPB1, HLA-DQA1, HLA-DQB1 and HLA-DRB1 gene alleles were associated with TA
      in Chinese Han population. And the clinical features of patients with TA were analyzed. The
      cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to
      monitor TA activity. But there are still many unknown fields in TA, such as the epidemiology
      and pathophysiology. This study is to build a Chinese national registry system for TA to
      obtain real-world information, such as current status of characteristics, diagnosis, disease
      activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis
      and development of effective treatment strategies.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Mortality of the patients with TA

Secondary Outcome

 The rate of the major cardiac and cerebrovascular events

Condition

TAKAYASU ARTERITIS



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

August 2016

Completion Date

July 2026

Primary Completion Date

July 2026

Eligibility Criteria

        Inclusion Criteria:

          -  Age at disease onset < 40 years. (Development of symptoms or findings related to
             Takayasu arteritis at age <40 years)

          -  Claudication of extremities. (Development and worsening of fatigue and discomfort in
             muscles of 1 or more extremity while in use, especially the upper extremities)

          -  Decreased brachial artery pulse. (Decreased pulsation of 1 or both brachial arteries)

          -  BP difference >10 mm Hg. (Difference of >10 mm Hg in systolic blood pressure between
             arms)

          -  Bruit audible on auscultation over 1 or both subclavian arteries or abdominal aorta.

          -  Arteriogram abnormality. (Arteriographic narrowing or occlusion of the entire aorta,
             its primary branches, or large arteries in the proximal upper or lower extremities,
             not due to arteriosclerosis, fibromuscular dysplasia, or similar causes; changes
             usually focal or segmental)

        Exclusion Criteria:

          -  Vessel lesions that could be entirely due to atherosclerosis.

          -  Giant cell arteritis or other infectious forms of large vessel vasculitis.
      

Gender

All

Ages

5 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, +8610-88322131, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02964364

Organization ID

NSFC 30770859


Responsible Party

Sponsor-Investigator

Study Sponsor

Aimin Dang


Study Sponsor

, , 


Verification Date

September 2016