Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1067 participants
OBSERVATIONAL
2017-01-01
2020-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Takayasu arteritis
All recruited Takayasu arteritis patients.
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.
laboratory biomarker analysis
Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.
genetic sequencing
Genetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis.
Interventions
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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.
laboratory biomarker analysis
Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.
genetic sequencing
Genetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
ALL
Yes
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Huimin Zhang, MD.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Jun Cai, MD.PhD.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Chinese Academy of Medical Sciences Fuwai Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2016-ZX43
Identifier Type: -
Identifier Source: org_study_id
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