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Registration Study of Takayasu's Arteritis in China (TA-China)

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ClinicalTrials.gov Identifier: NCT03199183
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

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.

Condition or disease Intervention/treatment
Takayasu Arteritis Radiation: PET-CT Other: laboratory biomarker analysis Genetic: genetic sequencing

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1067 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: Registration Study of Takayasu's Arteritis in China
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Takayasu arteritis
All recruited Takayasu arteritis patients.
Radiation: PET-CT
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.

Other: laboratory biomarker analysis
Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.

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




Primary Outcome Measures :
  1. prevalence rate [ Time Frame: 1 year ]
    the percentage of Takayasu arteritis patients among general population (estimated) during one-year period


Secondary Outcome Measures :
  1. survival rate or mortality rate [ Time Frame: 1 year, at 3-month interval ]
    the percentage of alive or dead recruits

  2. rehospitalization rate [ Time Frame: 1 year, at 3-month interval ]
    the percentage of readmission to hospitals or centers


Biospecimen Retention:   Samples With DNA
All participants will have samples with DNA taken for laboratory biomarker analysis or genetic sequencing.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Takayasu arteritis patients diagnosed in all participant centers.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199183


Contacts
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Contact: Luyun Fan, MD. 01088398249 katevan@163.com
Contact: Huimin Zhang, MD. 01088398249 fwzhanghuimin@163.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences Fuwai Hospital Recruiting
Beijing, Beijing, China, Xichen District
Contact: Huimin Zhang, MD.    010-88398249    fwzhanghuimin@163.com   
Contact: Jun Cai, MD.PhD.    010-88322165    caijun@fuwaihospital.org   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: Huimin Zhang, MD. Chinese Academy of Medical Sciences, Fuwai Hospital
Principal Investigator: Jun Cai, MD.PhD. Chinese Academy of Medical Sciences, Fuwai Hospital

Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03199183     History of Changes
Other Study ID Numbers: 2016-ZX43
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Consent for sharing of non identifiable study data for regulatory authorities.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China National Center for Cardiovascular Diseases:
Takayasu Arteritis
registry

Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases