NCT03199183

Brief Summary

Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta and its major branches. The demographic, clinical and prognostic features of Takayasu arteritis in China remains in uncertainties. Investigators aim to setup a national registration study for Takayasu arteritis, to observe the prevalence, clinical manifestations, natural history, survival, progression, diagnostic and therapeutic methods of the disease in China.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,067

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

June 23, 2017

Last Update Submit

January 24, 2019

Conditions

Takayasu Arteritis

Keywords

Takayasu Arteritisregistry

Outcome Measures

Primary Outcomes (1)

  • prevalence rate

    the percentage of Takayasu arteritis patients among general population (estimated) during one-year period

    1 year

Secondary Outcomes (2)

  • survival rate or mortality rate

    1 year, at 3-month interval

  • rehospitalization rate

    1 year, at 3-month interval

Study Arms (1)

Takayasu arteritis

All recruited Takayasu arteritis patients.

Radiation: PET-CTOther: laboratory biomarker analysisGenetic: genetic sequencing

Interventions

PET-CTRADIATION

PET-CT will be proceed on the basis of clinical status and aspiration of individual patient. The imaging results will be analysed by professional radiologists.

Takayasu arteritis
laboratory biomarker analysisOTHER

Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.

Takayasu arteritis
genetic sequencingGENETIC

Genetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis.

Takayasu arteritis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Takayasu arteritis patients diagnosed in all participant centers.

You may qualify if:

  • All of the patients diagnosed in participating clinical centers with Takayasu arteritis fulfilled the American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis or the 1996 revised diagnostic criteria for Takayasu arteritis from Ishikawa K by Sharma BK et al. Patients highly suspected as Takayasu arteritis but uncertain in local centers can apply for assistant diagnosis of senior medical institutions.

You may not qualify if:

  • Manifestations caused by other diseases: atherosclerosis, fibromuscular dysplasia, Bechet's disease, giant cell arteritis, congenital vascular malformation, syphilis and other infections resulting in vasculitis.
  • Pregnant women and lactating women.
  • None indications for Takayasu arteritis from ultrasound, computed tomographic angiography, magnetic resonance angiography, digital subtraction angiography.
  • Absence of patient consents or dropout during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences Fuwai Hospital

Beijing, Beijing Municipality, Xichen District, China

RECRUITING

Related Publications (7)

  • Ishikawa K. Diagnostic approach and proposed criteria for the clinical diagnosis of Takayasu's arteriopathy. J Am Coll Cardiol. 1988 Oct;12(4):964-72. doi: 10.1016/0735-1097(88)90462-7.

    PMID: 2901440BACKGROUND

  • Arend WP, Michel BA, Bloch DA, Hunder GG, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis. Arthritis Rheum. 1990 Aug;33(8):1129-34. doi: 10.1002/art.1780330811.

    PMID: 1975175BACKGROUND

  • Yang L, Zhang H, Jiang X, Zou Y, Qin F, Song L, Guan T, Wu H, Xu L, Liu Y, Zhou X, Bian J, Hui R, Zheng D. Clinical manifestations and longterm outcome for patients with Takayasu arteritis in China. J Rheumatol. 2014 Dec;41(12):2439-46. doi: 10.3899/jrheum.140664. Epub 2014 Oct 1.

    PMID: 25274886BACKGROUND

  • Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. doi: 10.1016/s0167-5273(96)88783-3.

    PMID: 9119516BACKGROUND

  • Fan L, Yang L, Wei D, Ma W, Lou Y, Song L, Bian J, Zhang H, Cai J. Clinical Scenario and Long-Term Outcome of Childhood Takayasu Arteritis Undergoing 121 Endovascular Interventions: A Large Cohort Over a Fifteen-Year Period. Arthritis Care Res (Hoboken). 2021 Nov;73(11):1678-1688. doi: 10.1002/acr.24387. Epub 2021 Oct 13.

    PMID: 32702156DERIVED

  • Fan L, Zhang H, Cai J, Yang L, Wei D, Yu J, Fan J, Song L, Ma W, Lou Y. Clinical Course, Management, and Outcomes of Pediatric Takayasu Arteritis Initially Presenting With Hypertension: A 16-year overview. Am J Hypertens. 2019 Sep 24;32(10):1021-1029. doi: 10.1093/ajh/hpz103.

    PMID: 31278892DERIVED

  • Fan L, Zhang H, Cai J, Yang L, Liu B, Wei D, Yu J, Fan J, Song L, Ma W, Zhou X, Wu H, Lou Y. Clinical course and prognostic factors of childhood Takayasu's arteritis: over 15-year comprehensive analysis of 101 patients. Arthritis Res Ther. 2019 Jan 22;21(1):31. doi: 10.1186/s13075-018-1790-x.

    PMID: 30670069DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

All participants will have samples with DNA taken for laboratory biomarker analysis or genetic sequencing.

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huimin Zhang, MD.

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

  • Jun Cai, MD.PhD.

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luyun Fan, MD.

CONTACT

01088398249katevan@163.com

Huimin Zhang, MD.

CONTACT

01088398249fwzhanghuimin@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 26, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

CN(1)