Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)

NCT ID: NCT05865054

Last Updated: 2025-09-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-29

Study Completion Date

2033-07-31

Brief Summary

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The research study is being conducted to determine the utility of magnetic resonance imaging (MRI) in identifying inflammation of arteries supplying blood to the head, brain, and eyes. The target population includes patient with suspected giant cell arteritis (GCA; temporal arteritis).

Detailed Description

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After signing the consent form, participants will complete an MRI scan within 2 weeks of enrollment and fill out questionnaires related to their disease. Follow up visits and MRI scans may occur at 6-months after the initial MRI scan or at the time of relapse.

Conditions

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Giant Cell Arteritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DIAGNOSTIC_TEST

Combined orbital and cranial vessel wall MRI

Non-Ocular GCA

GCA without ocular manifestations

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

Combined orbital and cranial vessel wall MRI

Non-GCA

Initially suspected to have GCA but final clinical diagnosis not GCA

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

Combined orbital and cranial vessel wall MRI

Interventions

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Magnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 50 years or older
* 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

* Contra-indication to receiving MRI including:

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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Rennie Rhee, M.D., MSCE

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

3400 Civic Center Blvd

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

University Hospital Wuerzburg

Würzburg, Würzburg, Germany

Site Status NOT_YET_RECRUITING

Countries

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United States Canada Germany

Central Contacts

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Brenda Hernandez-Romero, B.S

Role: CONTACT

917-548-2067

Facility Contacts

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Jennifer Sletten

Role: primary

507-284-3695

Brenda Hernandez-Romero, B.S

Role: primary

917-548-2067

Sandra Messier

Role: primary

905-573-4823

Carmen Müglich

Role: primary

49 931 201 40112

Other Identifiers

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R01AR084199-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

843171

Identifier Type: -

Identifier Source: org_study_id

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