Registration Study of Takayasu's Arteritis in China | NCT03199183

Studies
Registration Study of Takayasu's Arteritis in China

NCT03199183

Sponsor

China National Center for Cardiovascular Diseases

Status

Unknown status

Last Update Posted

Jan 25, 2019Actual

Enrollment

1,067Estimated

Phase

Not provided

Conditions

Takayasu Arteritis

Interventions

PET-CT
laboratory biomarker analysis
genetic sequencing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

Jun 23, 2017

First Submission Date that Met QC Criteria

Jun 23, 2017

First Posted Date

Jun 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2019

Last Update Posted Date

Jan 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.
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.
Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till reaching a total of 1067 registered patients.
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,067Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Takayasu arteritis		All recruited Takayasu arteritis patients.	Radiation: PET-CT Other: laboratory biomarker analysis Genetic: genetic sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET-CT	Radiation	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
survival rate or mortality rate	the percentage of alive or dead recruits	1 year, at 3-month interval
rehospitalization rate	the percentage of readmission to hospitals or centers

Other Outcomes

Not provided

Eligibility Module

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:

Manifestations caused by other diseases: atherosclerosis, fibromuscular dysplasia, Bechet's disease, giant cell arteritis, congenital vascular malformation, syphilis and other infections resulting in vasculitis.
Pregnant women and lactating women.
None indications for Takayasu arteritis from ultrasound, computed tomographic angiography, magnetic resonance angiography, digital subtraction angiography.
Absence of patient consents or dropout during the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Takayasu arteritis patients diagnosed in all participant centers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luyun Fan, MD.	Contact	01088398249		katevan@163.com
Huimin Zhang, MD.	Contact	01088398249		fwzhanghuimin@163.com

Overall Officials

Name	Affiliation	Role
Huimin Zhang, MD.	Chinese Academy of Medical Sciences, Fuwai Hospital	Principal Investigator
Jun Cai, MD.PhD.	Chinese Academy of Medical Sciences, Fuwai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese Academy of Medical Sciences Fuwai Hospital	Recruiting	Beijing	Beijing Municipality	Xichen District	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2901440	Background	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. doi: 10.1016/0735-1097(88)90462-7.
1975175	Background	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. doi: 10.1002/art.1780330811.

ID	Term
D001015	Aortic Arch Syndromes
D001018	Aortic Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases