The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions: 1. What is the performance of ONSD to identify patients with new-onset, active GCA? 2. Is ONSD useful for monitoring GCA relapses during follow-up? 3. What is the intra- and interobserver reliability of ONSD measurements? 4. Does ONSD differ between patients with and without GCA-related retinal findings?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ To be included in SONIC-GCA, participants must meet all the following criteria:

• Age \> 50 years.

• Referral to a GCA clinic for suspected, new-onset GCA.

• Ability to understand and willingness to sign an informed consent form.

• Willingness to comply with study visits and procedures.

Locations
Other Locations
Canada
St-Joseph's Health Care London
NOT_YET_RECRUITING
London
CIUSSS de l'Est-de-l'ile de Montreal
NOT_YET_RECRUITING
Montreal
MUHC - McGill University
NOT_YET_RECRUITING
Montreal
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
RECRUITING
Montreal
CIUSSS de l'Estrie - CHUS
NOT_YET_RECRUITING
Sherbrooke
Sinai Health - Toronto
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Jean-Paul Makhzoum, MD
jean-paul.makhzoum@umontreal.ca
5143382222
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2029-03
Participants
Target number of participants: 285
Treatments
GCA group
Ascertainment of GCA will occur 6 months after study inclusion and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive diagnostic test for GCA, including ultrasound of temporal arteries, temporal artery biopsy, cranial MRI or cranial PET; and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA.~Study visits :~Baseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)
Non-GCA group
Participants who do not meet the composite clinical test validation for GCA (above).~Study visits : Baseline and Month 6 (phone follow-up)
Related Therapeutic Areas
Temporal Arteritis
Giant Cell Arteritis (GCA)
Vasculitis
Sponsors
Leads: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre, Ciusss de L'Est de l'Île de Montréal, St. Joseph's Health Care London, Mount Sinai Hospital, Canada, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke, Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov

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