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