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A Registry Study on Biomarkers of Takayasu's Arteritis (ARSBTA)

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ClinicalTrials.gov Identifier: NCT03372980
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
Peking University People's Hospital
Information provided by (Responsible Party):
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief 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. 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.

Condition or disease
Takayasu's Arteritis

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Registry Study on Biomarkers of Takayasu's Arteritis
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Case
Control



Primary Outcome Measures :
  1. 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.

  2. 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.



Biospecimen Retention:   Samples With DNA
Blood samples,Cells,Tissues


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Case group consists of patients who was diagnosed as Takayasu's Arteritis; control group is general population without Takayasu's Arteritis.
Criteria

Retrospective

Inclusion Criteria:

Subjects who met the American College of Rheumatology 1990 classification criteria for Takayasu arteritis:

  1. Age of onset ≤40 years,
  2. Claudication of upper or lower extremities,
  3. Decreased pulsation of 1 or both brachial arteries,
  4. Difference of ≥ 10 mmHg in systolic blood pressure between arms,
  5. Bruit over subclavian arteries or aorta,
  6. *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:

  1. Arteriographic lesions that could be entirely due to atherosclerosis,
  2. Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.) besides Takayasu arteritis,
  3. Cogan's syndrome,
  4. Behcet's disease,
  5. Subjects with any serious acute or chronic infection,
  6. 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:

  1. Patients without image studies.
  2. Patients with confirmed other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus erythematosus, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372980


Contacts
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Contact: Yuan WANG, PhD 86-010-64456169 wangyuan980510@163.com
Contact: Fengjuan LI, PhD 86-010-64456165 lifjgogo@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Yuan WANG, PhD    86-010-64456169    wangyuan980510@163.com   
Principal Investigator: Jie DU, PhD         
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Shanghai Zhongshan Hospital
Peking University People's Hospital

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Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
ClinicalTrials.gov Identifier: NCT03372980     History of Changes
Other Study ID Numbers: ARSBTA
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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

Keywords provided by Beijing Institute of Heart, Lung and Blood Vessel Diseases:
Biomarkers

Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases