China Takayasu Arteritis Registry (CTA Registry)

TAKAYASU ARTERITIS Clinical Trial

Official title:

China Takayasu Arteritis Registry (CTA Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964364
• Other study ID #: NSFC 30770859
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2016
• Last updated: November 13, 2016
• Start date: August 2016
• Est. completion date: July 2026

Study information

• Verified date: September 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Aimin Dang, MD,PhD
• Phone: +8610-88322131
• Email: aimindangfw[@]gmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteritis
• Takayasu Arteritis

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Aimin Dang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality of the patients with TA	All-caused death at 10 years.	10 years (2016-2026)	No
Secondary	The rate of the major cardiac and cerebrovascular events	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.	10 years (2016-2026)	No