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NCT Number: NCT02964364

China Takayasu Arteritis Registry (CTA Registry)

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.

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Key information

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Aimin Dang, Doctor

PRINCIPAL_INVESTIGATOR

Naqiang Lv, Doctor

CONTACT

[email protected]

+8610-88322131

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality of the patients with TA

    Time frame: 10 years (2016-2026)

    All-caused death at 10 years.

Secondary outcomes

  1. The rate of the major cardiac and cerebrovascular events

    Time frame: 10 years (2016-2026)

    the major cardiac and cerebrovascular events (MACCE) defined as the composite of all heart failure, all stroke, all myocardial infarction (MI), or any revascularization at 10 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Aimin Dang, MD,PhD

CONTACT

[email protected]

+8610-88322131

Naqiang lv, MD,PhD

CONTACT

[email protected]

+8610-88322131

Sponsors and collaborators

Lead sponsor

Aimin Dang

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Nov 16, 2016
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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