TA-China: Registration Study of Takayasu's Arteritis in China
Study Details
Study Description
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 | Phase |
|---|---|---|
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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:
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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.
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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.
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Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till reaching a total of 1067 registered patients.
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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.
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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 Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- prevalence rate [1 year]
the percentage of Takayasu arteritis patients among general population (estimated) during one-year period
Secondary Outcome Measures
- survival rate or mortality rate [1 year, at 3-month interval]
the percentage of alive or dead recruits
- rehospitalization rate [1 year, at 3-month interval]
the percentage of readmission to hospitals or centers
Eligibility Criteria
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:
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Manifestations caused by other diseases: atherosclerosis, fibromuscular dysplasia, Bechet's disease, giant cell arteritis, congenital vascular malformation, syphilis and other infections resulting in vasculitis.
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Pregnant women and lactating women.
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None indications for Takayasu arteritis from ultrasound, computed tomographic angiography, magnetic resonance angiography, digital subtraction angiography.
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Absence of patient consents or dropout during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese Academy of Medical Sciences Fuwai Hospital | Beijing | Beijing | China | Xichen District |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. Review.
- 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.
- 2016-ZX43