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Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)

Recruiting
Conditions
Giant Cell Arteritis
Registration Number
NCT05865054
Lead Sponsor
University of Pennsylvania
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 with suspected giant cell arteritis (GCA; temporal arteritis).

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 6-months after the initial MRI scan or at the time of relapse.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
400
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Vessel Wall Enhancement ScoreUp to 12 months

Enhancement of cranial vessel wall, orbital structures, or other cranial structures. Scores range from 0 to 3; 0 being no inflammation and 3 being more enhancement or inflammation.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

3400 Civic Center Blvd

🇺🇸

Philadelphia, Pennsylvania, United States

3400 Civic Center Blvd
🇺🇸Philadelphia, Pennsylvania, United States
Brenda Hernandez-Romero, B.S
Contact
917-548-2067
Brenda_Hernandez-Romero@pennmedicine.upenn.edu
Rennie Rhee, MD
Principal Investigator

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