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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

Tracking Information
First Submitted Date August 21, 2016
First Posted Date November 16, 2016
Last Update Posted Date November 16, 2016
Study Start Date August 2016
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2016)
Mortality of the patients with TA [ Time Frame: 10 years (2016-2026) ]
All-caused death at 10 years.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 13, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title China Takayasu Arteritis Registry (CTA Registry)
Official Title China Takayasu Arteritis Registry (CTA Registry)
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals with TA. Participants will have disease in various stages and of different duration.
Condition TAKAYASU ARTERITIS
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2026
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Aimin Dang, MD,PhD +8610-88322131 aimindangfw@gmail.com
Contact: Naqiang lv, MD,PhD +8610-88322131 lvnaqiang@gmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02964364
Other Study ID Numbers NSFC 30770859
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Medical clinical data base
Responsible Party Aimin Dang, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor Aimin Dang
Collaborators Not Provided
Investigators Not Provided
PRS Account Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date September 2016