Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2020-07-29
2033-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ocular GCA
GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition
Magnetic Resonance Imaging (MRI)
Combined orbital and cranial vessel wall MRI
Non-Ocular GCA
GCA without ocular manifestations
Magnetic Resonance Imaging (MRI)
Combined orbital and cranial vessel wall MRI
Non-GCA
Initially suspected to have GCA but final clinical diagnosis not GCA
Magnetic Resonance Imaging (MRI)
Combined orbital and cranial vessel wall MRI
Interventions
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Magnetic Resonance Imaging (MRI)
Combined orbital and cranial vessel wall MRI
Eligibility Criteria
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Inclusion Criteria
* First presentation of suspected GCA
* New or worsening cranial manifestations within 4 weeks of enrollment concerning for active GCA
* Elevated CRP greater than 1.0 mg/dl
* Plan to undergo temporal artery biopsy or ultrasound for diagnosis
Exclusion Criteria
Implanted medical devices, pacemaker, and metallic foreign fragments inside body/orbits Known gadolinium allergy Women who are pregnant or nursing
* Absence of cranial symptoms related to GCA (e.g., only large vessel GCA)
50 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Rennie Rhee, M.D., MSCE
Assistant Professor of Medicine
Principal Investigators
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Rennie Rhee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Mayo Building and Gonda Building
Rochester, Minnesota, United States
3400 Civic Center Blvd
Philadelphia, Pennsylvania, United States
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
University Hospital Wuerzburg
Würzburg, Würzburg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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843171
Identifier Type: -
Identifier Source: org_study_id
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