Clinical trial NCT02964364: China Takayasu Arteritis Registry (CTA Registry)
Official title: China Takayasu Arteritis Registry (CTA Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: TAKAYASU ARTERITIS
Keywords: TAKAYASU ARTERITIS
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with TA. Participants will have disease in various stages and of different duration.

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.

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.

Primary outcomes:
measure: Mortality of the patients with TA
timeFrame: 10 years （2016-2026）
Secondary outcomes:
measure: The rate of the major cardiac and cerebrovascular events
timeFrame: 10 years （2016-2026）
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References: