Registration Study of Takayasu’s Arteritis in China

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Brief Title

Registration Study of Takayasu's Arteritis in China

Official Title

Registration Study of Takayasu's Arteritis in China

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.
    

Detailed Description

      Objective: The study aims to investigate the demographic, clinical and prognostic features
      and to draw the diagnostic and therapeutic algorithm of Takayasu arteritis in China.

      Study Type: A national, multicenter, observational, ambispective cohort study.

      Study Design: The cardinal contents of this registry study are as follows:

        1. Select representative clinical centers through typical sampling methods and train the
           local investigators in basic knowledge of Takayasu arteritis. Introduce the Electronic
           Data Capture System and train in completing case report forms.

        2. Collect demographic, clinical, imaging, laboratory, diagnostic and therapeutic
           information of Takayasu arteritis patients hospitalized from Jan 1st 2002 to now. Build
           a baseline database of Takayasu arteritis patients.

        3. Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till
           reaching a total of 1067 registered patients.

        4. Gather the 3-month, 6-month, 1-year follow up information including general, clinical,
           therapeutic, prognostic data of all recruits and build up the follow-up database.

        5. Establish bio-bank for serum/plasma, urine, stool, tissues or cells.

      Data management, quality control and statistic analysis: Electronic Data Capture System has
      been built and the investigators will manage and analyze data in align with key indicators.
      The investigators have invited professional statistic analysts to assist analyzing data and a
      third party to supervise data quality.

      Ethics: The Ethics Committee of Fuwai Hospital approved this study and following ethical
      supports from participating centers are required. Informed consents before patient enrollment
      are required.
    


Study Type

Observational [Patient Registry]


Primary Outcome

prevalence rate

Secondary Outcome

 survival rate or mortality rate

Condition

Takayasu Arteritis

Intervention

PET-CT

Study Arms / Comparison Groups

 Takayasu arteritis
Description:  All recruited Takayasu arteritis patients.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

1067

Start Date

January 1, 2017

Completion Date

July 1, 2020

Primary Completion Date

July 1, 2020

Eligibility Criteria

        Inclusion Criteria:

        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.

        Exclusion Criteria:

          1. Manifestations caused by other diseases: atherosclerosis, fibromuscular dysplasia,
             Bechet's disease, giant cell arteritis, congenital vascular malformation, syphilis and
             other infections resulting in vasculitis.

          2. Pregnant women and lactating women.

          3. None indications for Takayasu arteritis from ultrasound, computed tomographic
             angiography, magnetic resonance angiography, digital subtraction angiography.

          4. Absence of patient consents or dropout during the study.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Huimin Zhang, MD., 01088398249, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03199183

Organization ID

2016-ZX43


Responsible Party

Sponsor

Study Sponsor

China National Center for Cardiovascular Diseases


Study Sponsor

Huimin Zhang, MD., Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital


Verification Date

January 2019