An observational study in Takayasu's Arteritis, sponsored by Beijing Institute of Heart, Lung and Blood Vessel Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by Beijing Institute of Heart, Lung and Blood Vessel Diseases · Observational
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.
78 studies on the registry are indexed under Takayasu Arteritis; 32 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 224 across 41 observational studies indexed under Takayasu Arteritis.
Browse Takayasu Arteritis studies →Beijing Institute of Heart, Lung and Blood Vessel Diseases is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Case group consists of patients who was diagnosed as Takayasu's Arteritis; control group is general population without Takayasu's Arteritis.
Retrospective
Inclusion Criteria:
Subjects who met the American College of Rheumatology 1990 classification criteria for Takayasu arteritis:
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:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
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.
Started Jan 2016 (actual). Primary completion is estimated for Dec 2026, 131 months after the start.
How these figures are worked out, and which studies are left out of them.
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Beijing Institute of Heart, Lung and Blood Vessel Diseases