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NCT02257866
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Conditions: Takayasu's Arteritis, Giant Cell Arteritis, Polyarteritis Nodosa, Relapsing Polychondritis, ANCA-Associated Vasculitis
Sex: All
Ages: 3 Years – N/A
Healthy volunteers: Yes
Enrollment: 4000
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Location: National Institutes of Health Clinical Center Bethesda Maryland
Summary
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.
Eligibility Criteria
* 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
Source: ClinicalTrials.gov (NCT02257866). StuddyBuddy aggregates publicly available trial information.