China Takayasu Arteritis Registry (CTA Registry)

Sponsor
Aimin Dang (Other)
Overall Status
Recruiting
CT.gov ID
NCT02964364
Collaborator
(none)
1,000
1
119
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    China Takayasu Arteritis Registry (CTA Registry)
    Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Jul 1, 2026
    Anticipated Study Completion Date :
    Jul 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Mortality of the patients with TA [10 years (2016-2026)]

      All-caused death at 10 years.

    Secondary Outcome Measures

    1. The rate of the major cardiac and cerebrovascular events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuwai Hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • Aimin Dang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aimin Dang, Fuwai Hospital, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences, Fuwai Hospital
    ClinicalTrials.gov Identifier:
    NCT02964364
    Other Study ID Numbers:
    • NSFC 30770859
    First Posted:
    Nov 16, 2016
    Last Update Posted:
    Nov 16, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Aimin Dang, Fuwai Hospital, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences, Fuwai Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2016