VEGA: Vessel Wall Enhancement in Giant Cell Arteritis

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05865054

Collaborator

(none)

400

Enrollment

Location

71.1

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 diagnosed with giant cell arteritis (GCA; temporal arteritis).

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Arteritis	Diagnostic Test: Magnetic Resonance Imaging (MRI)

Detailed Description

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 1-month, 6-months, 12-months after the initial MRI scan or at the time of relapse.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vessel Wall Enhancement in Giant Cell Arteritis: The VEGA Study

Actual Study Start Date :

Jul 29, 2020

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Ocular GCA GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition	Diagnostic Test: Magnetic Resonance Imaging (MRI) Combined orbital and cranial vessel wall MRI
Non-Ocular GCA GCA without ocular manifestations	Diagnostic Test: Magnetic Resonance Imaging (MRI) Combined orbital and cranial vessel wall MRI
Non-GCA Initially suspected to have GCA but final clinical diagnosis not GCA	Diagnostic Test: Magnetic Resonance Imaging (MRI) Combined orbital and cranial vessel wall MRI

Arm

Intervention/Treatment

Ocular GCA

GCA with clinical diagnosis of ischemic optic neuropathy or other ocular condition

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Non-Ocular GCA

GCA without ocular manifestations

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Non-GCA

Initially suspected to have GCA but final clinical diagnosis not GCA

Diagnostic Test: Magnetic Resonance Imaging (MRI)

Combined orbital and cranial vessel wall MRI

Outcome Measures

Primary Outcome Measures

MRI enhancement score [Up to 12 months]
Enhancement of cranial vessel wall, orbital structures, or other cranial structures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participant must be in one of the following groups:

Suspected new diagnosis of GCA
Suspected relapse of GCA (new or worsening symptoms attributed to active GCA) in patient with previously established diagnosis of GCA

The participant must have (or previously had) cranial manifestations related to or concerning for GCA including: visual symptoms, headache, temporal artery tenderness, jaw claudication, scalp tenderness, or stroke
Participant must be within 14 days of initiating or escalating systemic glucocorticoids (e.g., prednisone) OR have ongoing cranial symptoms concerning for active disease at time of baseline MRI.
Participants who are receiving a clinically-indicated MRI at the time of enrollment may participate even if they meet exclusion criteria of creatinine clearance less than 30 ml/min or mild gadolinium allergy
Participants must sign the informed consent form

Exclusion Criteria:

Contra-indication to receiving MRI including:
Implanted medical devices, pacemaker and metallic foreign fragments inside body or orbit
Known gadolinium allergy
Estimated glomerular filtration rate less than 30 ml/min/1.73m2
Claustrophobia
Women who are pregnant or nursing