China Takayasu Arteritis Registry (CTA Registry)

November 13, 2016 updated by: Aimin Dang

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Aimin Dang, MD,PhD
Phone Number: +8610-88322131
Email: aimindangfw@gmail.com

Study Contact Backup

Name: Naqiang lv, MD,PhD
Phone Number: +8610-88322131
Email: lvnaqiang@gmail.com

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100037
    - Recruiting
    - Fuwai Hospital
    - Contact:
      
      Naqiang Lv, Doctor
      
      Phone Number: +8610-88322131
      
      Email: lvnaqiang@gmail.com
    - Principal Investigator:
      
      Aimin Dang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with TA. Participants will have disease in various stages and of different duration.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality of the patients with TA Time Frame: 10 years （2016-2026）	All-caused death at 10 years.	10 years （2016-2026）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years （2016-2026）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aimin Dang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

November 13, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Estimate)