Registration Study of Takayasu's Arteritis in China

• Conditions: Takayasu Arteritis
• Interventions: Radiation: PET-CT; Other: laboratory biomarker analysis; Genetic: genetic sequencing

• Registration Number: NCT03199183
• Lead Sponsor: China National Center for Cardiovascular Diseases

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-25
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1067

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Takayasu arteritis	laboratory biomarker analysis	All recruited Takayasu arteritis patients.
Takayasu arteritis	genetic sequencing	All recruited Takayasu arteritis patients.
Takayasu arteritis	PET-CT	All recruited Takayasu arteritis patients.

Primary Outcome Measures

Name	Time	Method
prevalence rate	1 year	the percentage of Takayasu arteritis patients among general population (estimated) during one-year period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences Fuwai Hospital; 🇨🇳 Beijing, Beijing, China