TAKAYASU ARTERITISNCT02964364
China Takayasu Arteritis Registry (CTA Registry)
An observational study of TAKAYASU ARTERITIS, run by Aimin Dang at 1 site in China.
Trial summary
Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta and its major branches. The epidemiology and pathophysiology of TA is still unclear in China, although many studies have been done. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- TAKAYASU ARTERITIS
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with TA. Participants will have disease in various stages and of different duration.
Who may be able to join
- Age at disease onset < 40 years. (Development of symptoms or findings related to Takayasu arteritis at age <40 years)
- Claudication of extremities. (Development and worsening of fatigue and discomfort in muscles of 1 or more extremity while in use, especially the upper extremities)
- Decreased brachial artery pulse. (Decreased pulsation of 1 or both brachial arteries)
- BP difference >10 mm Hg. (Difference of >10 mm Hg in systolic blood pressure between arms)
- Bruit audible on auscultation over 1 or both subclavian arteries or abdominal aorta.
- Arteriogram abnormality. (Arteriographic narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities, not due to arteriosclerosis, fibromuscular dysplasia, or similar causes; changes usually focal or segmental)
Who cannot join
- Vessel lesions that could be entirely due to atherosclerosis.
- Giant cell arteritis or other infectious forms of large vessel vasculitis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Naqiang Lv, Doctor, +8610-88322131, lvnaqiang@gmail.com
Aimin Dang, Doctor
About this study
Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta and its major branches. The epidemiology and pathophysiology of TA is still unclear in China, although many studies have been done. Our previous study supporting by National Natural Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were associated with TA in Chinese han population. Further investigations with larger samples are needed to fully understand the a pathophysiology of TA. The purpose of this study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective disease monitoring and treatment strategies.
Read the detailed description
Takayasu arteritis (TA) is a chronic vasculitis that causes inflammation of the aorta and its main branches and is characterized by adventitial thickening and cellular infiltration of the tunica media, with local destruction of vascular smooth muscle cells and elastin. The disease is very rare but most commonly occurs in China. In the last decade, the results of our study indicated that HLA-DPB1, HLA-DQA1, HLA-DQB1 and HLA-DRB1 gene alleles were associated with TA in Chinese Han population. And the clinical features of patients with TA were analyzed. The cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity. But there are still many unknown fields in TA, such as the epidemiology and pathophysiology. This study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective treatment strategies.
- Conditions
- TAKAYASU ARTERITIS
- Keywords
- TAKAYASU ARTERITIS
- Medical subject headings
- Takayasu Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of the patients with TA
All-caused death at 10 years.
Measured: 10 years （2016-2026）
Secondary outcomes (1)
The rate of the major cardiac and cerebrovascular events
the major cardiac and cerebrovascular events (MACCE) defined as the composite of all heart failure, all stroke, all myocardial infarction (MI), or any revascularization at 10 years.
Measured: 10 years （2016-2026）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAKAYASU ARTERITISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Aimin Dang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aimin Dang, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964364
- Sponsor's protocol ID
- NSFC 30770859
- Status last verified
- Sep 2016
- First submitted
- 21 Aug 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Medical clinical data base
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Takayasu Arteritis Registry (CTA Registry)
- ClinicalTrials.gov ID
- NCT02964364
- Acronym / sponsor ID
- NSFC 30770859
- Conditions
- TAKAYASU ARTERITIS
- Keywords
- TAKAYASU ARTERITIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Aimin DangUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Takayasu arteritis (TA) is a chronic large-vessel vasculitis that mainly affects the aorta and its major branches. The epidemiology and pathophysiology of TA is still unclear in China, although many studies have been done. Our previous study supporting by National Natural Science Foundation of China indicated the cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity, and HLA gene alleles were associated with TA in Chinese han population. Further investigations with larger samples are needed to fully understand the a pathophysiology of TA. The purpose of this study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective disease monitoring and treatment strategies.
Detailed description
Takayasu arteritis (TA) is a chronic vasculitis that causes inflammation of the aorta and its main branches and is characterized by adventitial thickening and cellular infiltration of the tunica media, with local destruction of vascular smooth muscle cells and elastin. The disease is very rare but most commonly occurs in China. In the last decade, the results of our study indicated that HLA-DPB1, HLA-DQA1, HLA-DQB1 and HLA-DRB1 gene alleles were associated with TA in Chinese Han population. And the clinical features of patients with TA were analyzed. The cytokines such as hs-CRP, NT-proBNP and tumor necrosis factor-alpha (TNF-α) can be used to monitor TA activity. But there are still many unknown fields in TA, such as the epidemiology and pathophysiology. This study is to build a Chinese national registry system for TA to obtain real-world information, such as current status of characteristics, diagnosis, disease activity, the severity of disease, treatment and outcomes of Chinese TA patients. To analysis and development of effective treatment strategies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with TA. Participants will have disease in various stages and of different duration.
Key inclusion criteria (6 listed)
- Age at disease onset < 40 years. (Development of symptoms or findings related to Takayasu arteritis at age <40 years)
- Claudication of extremities. (Development and worsening of fatigue and discomfort in muscles of 1 or more extremity while in use, especially the upper extremities)
- Decreased brachial artery pulse. (Decreased pulsation of 1 or both brachial arteries)
- BP difference >10 mm Hg. (Difference of >10 mm Hg in systolic blood pressure between arms)
- Bruit audible on auscultation over 1 or both subclavian arteries or abdominal aorta.
Key exclusion criteria (2 listed)
- Vessel lesions that could be entirely due to atherosclerosis.
- Giant cell arteritis or other infectious forms of large vessel vasculitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality of the patients with TA
Time frame: 10 years （2016-2026）
All-caused death at 10 years.
1 secondary outcome
The rate of the major cardiac and cerebrovascular events
Time frame: 10 years （2016-2026）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Individual participant dataSharing planned: Undecided. Medical clinical data base
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TAKAYASU ARTERITIS, run by Aimin Dang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aimin Dang, MD,PhD (+8610-88322131, aimindangfw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality of the patients with TA (time frame: 10 years （2016-2026）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.