NCT03199183

Registration Study of Takayasu's Arteritis in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,067 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2017-06-26
• Last updated: 2019-01-25

Locations

1 site across 1 country: China