Registration Study of Takayasu's Arteritis in China (TA-China)

• ClinicalTrials.gov Identifier: NCT03199183
• Recruitment Status: Unknown
• First Posted: June 26, 2017
• Last Update Posted: January 25, 2019
• Sponsor: China National Center for Cardiovascular Diseases
• Information provided by (Responsible Party): China National Center for Cardiovascular Diseases

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

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1067 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 12 Months
• Official Title: Registration Study of Takayasu's Arteritis in China
• Actual Study Start Date: January 1, 2017
• Estimated Primary Completion Date: July 1, 2020
• Estimated Study Completion Date: July 1, 2020

Groups and Cohorts

Group/Cohort

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.

Outcome Measures

Primary Outcome Measures :

1. prevalence rate [ Time Frame: 1 year ]
   the percentage of Takayasu arteritis patients among general population (estimated) during one-year period

Secondary Outcome Measures :

1. survival rate or mortality rate [ Time Frame: 1 year, at 3-month interval ]
   the percentage of alive or dead recruits
2. rehospitalization rate [ Time Frame: 1 year, at 3-month interval ]
   the percentage of readmission to hospitals or centers

Biospecimen Retention:   Samples With DNA

All participants will have samples with DNA taken for laboratory biomarker analysis or genetic sequencing.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Takayasu arteritis patients diagnosed in all participant centers.

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.

Contacts and Locations

Contacts

Contact: Luyun Fan, MD.; 01088398249; katevan@163.com

Contact: Huimin Zhang, MD.; 01088398249; fwzhanghuimin@163.com

Locations

China, Beijing

Chinese Academy of Medical Sciences Fuwai Hospital; Recruiting

Beijing, Beijing, China, Xichen District

Contact: Huimin Zhang, MD. 010-88398249 fwzhanghuimin@163.com

Contact: Jun Cai, MD.PhD. 010-88322165 caijun@fuwaihospital.org

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

More Information

Additional Information:

Publications:

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.

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.

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.

Sharma BK, Jain S, Suri S, Numano F. Diagnostic criteria for Takayasu arteritis. Int J Cardiol. 1996 Aug;54 Suppl:S141-7. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fan L, Zhang H, Cai J, Yang L, Wei D, Yu J, Fan J, Song L, Ma W, Lou Y. Clinical Course, Management, and Outcomes of Pediatric Takayasu Arteritis Initially Presenting With Hypertension: A 16-year overview. Am J Hypertens. 2019 Sep 24;32(10):1021-1029. doi: 10.1093/ajh/hpz103.

Fan L, Zhang H, Cai J, Yang L, Liu B, Wei D, Yu J, Fan J, Song L, Ma W, Zhou X, Wu H, Lou Y. Clinical course and prognostic factors of childhood Takayasu's arteritis: over 15-year comprehensive analysis of 101 patients. Arthritis Res Ther. 2019 Jan 22;21(1):31. doi: 10.1186/s13075-018-1790-x. Erratum in: Arthritis Res Ther. 2019 Feb 14;21(1):55.

• Responsible Party: China National Center for Cardiovascular Diseases
• ClinicalTrials.gov Identifier: NCT03199183
• Other Study ID Numbers: 2016-ZX43
• First Posted: June 26, 2017
• Last Update Posted: January 25, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Consent for sharing of non identifiable study data for regulatory authorities.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China National Center for Cardiovascular Diseases:

Takayasu Arteritis; registry

Additional relevant MeSH terms:

Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Skin Diseases, Vascular; Skin Diseases