NCT02964364

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

November 16, 2016

Status Verified

September 1, 2016

Enrollment Period

9.9 years

First QC Date

August 21, 2016

Last Update Submit

November 13, 2016

Conditions

Keywords

TAKAYASU ARTERITIS

Outcome Measures

Primary Outcomes (1)

  • Mortality of the patients with TA

    All-caused death at 10 years.

    10 years (2016-2026)

Secondary Outcomes (1)

  • The rate of the major cardiac and cerebrovascular events

    10 years (2016-2026)

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Vessel lesions that could be entirely due to atherosclerosis.
  • Giant cell arteritis or other infectious forms of large vessel vasculitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Aimin Dang, MD,PhD

CONTACT

Naqiang lv, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fuwai Hospital, Chinese Academy of Medical Sciences

Study Record Dates

First Submitted

August 21, 2016

First Posted

November 16, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

November 16, 2016

Record last verified: 2016-09

Locations