Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
Recruiting
NCT Number: NCT03372980
A Registry Study on Biomarkers of Takayasu's Arteritis (ARSBTA)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Retrospective
Inclusion criteria
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,
- *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).
Exclusion criteria
- 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.
Prospective
Inclusion criteria
Subjects with initial suspicion of having Takayasu arteritis or patients with Takayasu arteritis need assessment of disease activity were prospectively enrolled.
Exclusion criteria
- Patients without image studies.
- Patients with confirmed other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.)
Treatment and study plan
Primary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Fengjuan LI, PhD
CONTACT
Yuan WANG, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Other
Collaborators
- Peking University People's Hospital
- Shanghai Zhongshan Hospital
Registry information
Official study title
A Registry Study on Biomarkers of Takayasu's Arteritis
Important dates
- Study start
- 2016
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 14, 2017
- Registry last updated
- Apr 12, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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