Takayasu's ArteritisNCT03372980
A Registry Study on Biomarkers of Takayasu's Arteritis (ARSBTA)
An observational study of Takayasu's Arteritis, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
Takayasu arteritis is a chronic vasculitis mainly involving the aorta and its main branches such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as the coronary and pulmonary arteries. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Takayasu's Arteritis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case group consists of patients who was diagnosed as Takayasu's Arteritis; control group is general population without Takayasu's Arteritis.
Who may be able to join
- Subjects who met the American College of Rheumatology 1990 classification criteria for Takayasu arteritis:
- Age of onset ≤40 years,
- Claudication of upper or lower extremities,
- Decreased pulsation of 1 or both brachial arteries,
- Difference of ≥ 10 mmHg in systolic blood pressure between arms,
- Bruit over subclavian arteries or aorta,
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- *Arteriographic evidence showing a branch of the aorta stenosis or occlusion.
- Meeting more than 3 of 6 criteria suggests the diagnosis of Takayasu arteritis.
- Angiography in this study was replaced by vascular magnetic resonance angiography(MRA)or computed tomography angiography(CTA).
- Subjects with initial suspicion of having Takayasu arteritis or patients with Takayasu arteritis need assessment of disease activity were prospectively enrolled.
Who cannot join
- Arteriographic lesions that could be entirely due to atherosclerosis,
- Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.) besides Takayasu arteritis,
- Cogan's syndrome,
- Behcet's disease,
- Subjects with any serious acute or chronic infection,
- Giant cell arteritis (large vessel vasculitis and at least 50 years old) or other infectious forms of large vessel vasculitis.
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- Prospective
- Patients without image studies.
- Patients with confirmed other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yuan WANG, PhD, 86-010-64456169, wangyuan980510@163.com
Jie DU, PhD
About this study
Official title: A Registry Study on Biomarkers of Takayasu's Arteritis
Takayasu arteritis is a chronic vasculitis mainly involving the aorta and its main branches such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as the coronary and pulmonary arteries. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. However, there is a considerable lack of understanding of the disease mechanism of Takayasu arteritis. Initially, the disease remains clinically silent (or remains undetected) until the patients present with vascular occlusion. Additionally, many individuals with Takayasu arteritis, however, have no apparent symptoms despite disease activity. Therefore, biomarkers for diagnosis and monitor disease activity in individuals with Takayasu arteritis are needed. In this study, the investigators therefore to use different methods to identify new biomarkers for diagnosing or monitoring the disease activity in individuals with Takayasu arteritis. These biomarkers may provide valuable insights into the underlying biochemical processes and aid the understanding of the pathophysiology of this disease.
- Conditions
- Takayasu's Arteritis
- Keywords
- Biomarkers
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of each participant
Participant with Takayasu arteritis had image information from vascular magnetic resonance angiography (MRA) or computed tomography angiography (CTA) to confirm the final diagnosis.
Measured: These data is collected from the cases' medical record in an average of 3 month after the sample recruiting.
Disease activity of each participant
Criteria for Disease Activity：Criteria for active disease are detection of new vascular lesion or lesions in arteries on vascular Imaging in participants who had undergone magnetic resonance angiography (MRA) or computed tomography angiography (CTA) examination in the month before evaluation, or at least 2 of the following: 1) new onset of carotodynia or pain over large vessels, 2) transient ischemic episodes not attributable to other factors, 3) new bruit or new asymmetry in pulses or blood pressure determination, 4) ischemic symptoms (including new-onset claudication), and 5) fever in absence of infection.
Criteria defined inactive disease: 1) absence of the features of active disease for at least the previous 3 months; 2) absence of new vascular lesions and stability or improvement of previous vascular lesion or lesions on an imaging study performed up to 1 month before evaluation.
Measured: These data is collected from the cases' medical record or during follow-up visit in an average of 6 month after the sample recruiting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu's 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372980
- Sponsor's protocol ID
- ARSBTA
- Status last verified
- Apr 2022
- First submitted
- 4 Dec 2017
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study on Biomarkers of Takayasu's Arteritis
- ClinicalTrials.gov ID
- NCT03372980
- Acronym / sponsor ID
- ARSBTA
- Conditions
- Takayasu's Arteritis
- Keywords
- Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Peking University People's Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Dec 2017 (actual)
- 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 is a chronic vasculitis mainly involving the aorta and its main branches such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as the coronary and pulmonary arteries. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. However, there is a considerable lack of understanding of the disease mechanism of Takayasu arteritis. Initially, the disease remains clinically silent (or remains undetected) until the patients present with vascular occlusion. Additionally, many individuals with Takayasu arteritis, however, have no apparent symptoms despite disease activity. Therefore, biomarkers for diagnosis and monitor disease activity in individuals with Takayasu arteritis are needed. In this study, the investigators therefore to use different methods to identify new biomarkers for diagnosing or monitoring the disease activity in individuals with Takayasu arteritis. These biomarkers may provide valuable insights into the underlying biochemical processes and aid the understanding of the pathophysiology of this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case group consists of patients who was diagnosed as Takayasu's Arteritis; control group is general population without Takayasu's Arteritis.
Key inclusion criteria (10 listed)
- Subjects who met the American College of Rheumatology 1990 classification criteria for Takayasu arteritis:
- Age of onset ≤40 years,
- Claudication of upper or lower extremities,
- Decreased pulsation of 1 or both brachial arteries,
- Difference of ≥ 10 mmHg in systolic blood pressure between arms,
Key exclusion criteria (9 listed)
- Arteriographic lesions that could be entirely due to atherosclerosis,
- Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.) besides Takayasu arteritis,
- Cogan's syndrome,
- Behcet's disease,
- Subjects with any serious acute or chronic infection,
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
Diagnosis of each participant
Time frame: These data is collected from the cases' medical record in an average of 3 month after the sample recruiting.
Participant with Takayasu arteritis had image information from vascular magnetic resonance angiography (MRA) or computed tomography angiography (CTA) to confirm the final diagnosis.
Disease activity of each participant
Time frame: These data is collected from the cases' medical record or during follow-up visit in an average of 6 month after the sample recruiting.
Criteria for Disease Activity：Criteria for active disease are detection of new vascular lesion or lesions in arteries on vascular Imaging in participants who had undergone magnetic resonance angiography (MRA) or computed tomography angiography (CTA) examination in the month before evaluation, or at least 2 of the following: 1) new onset of carotodynia or pain over large vessels, 2) transient ischemic episodes not attributable to other factors, 3) new bruit or new asymmetry in pulses or blood pressure determination, 4) ischemic symptoms (including new-onset claudication), and 5) fever in absence of infection. Criteria defined inactive disease: 1) absence of the features of active disease for at least the previous 3 months; 2) absence of new vascular lesions and stability or improvement of previous vascular lesion or lesions on an imaging study performed up to 1 month before evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
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's Arteritis, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Apr 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan WANG, PhD (86-010-64456169, wangyuan980510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of each participant (time frame: These data is collected from the cases' medical record in an average of 3 month after the sample recruiting.). The study lists 2 primary outcomes in all. 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 12 Apr 2022.