Takayasu Arteritis Clinical Trial
— TA-ChinaOfficial title:
Registration Study of Takayasu's Arteritis in China
NCT number | NCT03199183 |
Other study ID # | 2016-ZX43 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | July 1, 2020 |
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.
Status | Recruiting |
Enrollment | 1067 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese Academy of Medical Sciences Fuwai Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
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. — View Citation
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. — View Citation
Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prevalence rate | the percentage of Takayasu arteritis patients among general population (estimated) during one-year period | 1 year | |
Secondary | survival rate or mortality rate | the percentage of alive or dead recruits | 1 year, at 3-month interval | |
Secondary | rehospitalization rate | the percentage of readmission to hospitals or centers | 1 year, at 3-month interval |
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