Giant Cell Arteritis Clinical Trial
Official title:
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Background: - Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can cause many medical problems. Few tests can diagnose the disease, and none can reliably predict a relapse. Researchers want to study people s genes and follow people over time to see how the disease affects them. Objective: - To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help identify people with vasculitis and predict what will happen to them over time. Eligibility: - People age 3 and older who have or are thought to have vasculitis, or are related to someone with it. - Healthy volunteers. Design: - Participants will be evaluated by a doctor who has expertise caring for patients with vasculitis. - Participants will give a blood sample. Some will give a urine sample. - Some participants may have brushings or biopsies taken from the inside lining of the nose. - Images of participants blood vessels may be taken using scans. For some scans, participants will lie on a table that moves in and out of a cylinder that takes pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans may use a radioactive form of sugar. Healthy minors will not have scans. - Some participants will answer questionnaires. - Some participants will have their tests done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples and send them to NIH. - Some participants will have one visit lasting 1-2 (but sometimes up to 4) days. Some participants may have follow-up visits every 3 - 6 months, indefinitely.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | January 1, 2050 |
Est. primary completion date | January 1, 2050 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years and older |
Eligibility | - INCLUSION CRITERIA: SUBJECTS WITH VASCULITIS - Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA31 and PAN - Subjects who fulfill the 1990 ACR Classification Criteria for EGPA, GCA, and TAK - Subjects who fulfill the 2012 Chapel Hill Nomenclature definition for MPA - Subjects with other suspected systemic or single-organ vasculitides HEALTHY VOLUNTEERS -Volunteers able to provide consent, or in the case of minors, assent EXCLUSION CRITERIA: SUBJECTS WITH VASCULITIS: - Subjects less than 3 years of age - Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion - Inability to provide consent, or in the case of minors, assent - Subjects with bleeding diathesis or on anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participation in nasal brushing or biopsy studies HEALTHY VOLUNTEERS - Volunteers less than 3 years of age - Diagnosis of vasculitis or other autoimmune/autoinflamamtory disease, including systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, mixed connective tissue disease or any overlap autoimmune syndrome - Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion - Pregnant (by history of last menstrual period) or breast feeding subjects - Subjects with bleeding diathesis or taking anticoagulant medications (eg coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
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Grayson PC, Alehashemi S, Bagheri AA, Civelek AC, Cupps TR, Kaplan MJ, Malayeri AA, Merkel PA, Novakovich E, Bluemke DA, Ahlman MA. 18 F-Fluorodeoxyglucose-Positron Emission Tomography As an Imaging Biomarker in a Prospective, Longitudinal Cohort of Patients With Large Vessel Vasculitis. Arthritis Rheumatol. 2018 Mar;70(3):439-449. doi: 10.1002/art.40379. Epub 2018 Feb 6. — View Citation
Quinn KA, Ahlman MA, Malayeri AA, Marko J, Civelek AC, Rosenblum JS, Bagheri AA, Merkel PA, Novakovich E, Grayson PC. Comparison of magnetic resonance angiography and 18F-fluorodeoxyglucose positron emission tomography in large-vessel vasculitis. Ann Rheum Dis. 2018 Aug;77(8):1165-1171. doi: 10.1136/annrheumdis-2018-213102. Epub 2018 Apr 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study the pathogenesis of patients affected with idiopathic systemic vasculitis, including clinical, radiographic, immunological, and genetic characteristics of the disease | To study the pathogenesis of patients affected with idiopathic systemic vasculitis, including clinical, radiographic, immunological, and genetic characteristics of the disease | end of study |
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