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China Takayasu Arteritis Registry (CTA Registry)

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ClinicalTrials.gov Identifier: NCT02964364
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Aimin Dang, Chinese Academy of Medical Sciences, Fuwai Hospital

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
TAKAYASU ARTERITIS

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 Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Years
Official Title: China Takayasu Arteritis Registry (CTA Registry)
Study Start Date : August 2016
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026





Primary Outcome Measures :
  1. Mortality of the patients with TA [ Time Frame: 10 years (2016-2026) ]
    All-caused death at 10 years.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with TA. Participants will have disease in various stages and of different duration.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964364


Contacts
Contact: Aimin Dang, MD,PhD +8610-88322131 aimindangfw@gmail.com
Contact: Naqiang lv, MD,PhD +8610-88322131 lvnaqiang@gmail.com

Locations
China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Naqiang Lv, Doctor    +8610-88322131    lvnaqiang@gmail.com   
Principal Investigator: Aimin Dang, Doctor         
Sponsors and Collaborators
Aimin Dang

Additional Information:

Responsible Party: Aimin Dang, Fuwai Hospital, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT02964364     History of Changes
Other Study ID Numbers: NSFC 30770859
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Medical clinical data base

Keywords provided by Aimin Dang, Chinese Academy of Medical Sciences, Fuwai Hospital:
TAKAYASU ARTERITIS

Additional relevant MeSH terms:
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases