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Clinical Trials/NCT02964364
NCT02964364
Recruiting
Not Applicable

China Takayasu Arteritis Registry (CTA Registry)

Aimin Dang1 site in 1 country1,000 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TAKAYASU ARTERITIS
Sponsor
Aimin Dang
Enrollment
1000
Locations
1
Primary Endpoint
Mortality of the patients with TA
Status
Recruiting
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2026
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aimin Dang
Responsible Party
Sponsor Investigator
Principal Investigator

Aimin Dang

Fuwai Hospital, Chinese Academy of Medical Sciences

Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Outcomes

Primary Outcomes

Mortality of the patients with TA

Time Frame: 10 years (2016-2026)

All-caused death at 10 years.

Secondary Outcomes

  • The rate of the major cardiac and cerebrovascular events(10 years (2016-2026))

Study Sites (1)

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