Actively Recruiting

Age: 50Years - 99Years
All Genders
NCT05749094

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Led by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Updated on 2025-08-07

285

Participants Needed

6

Research Sites

186 weeks

Total Duration

On this page

Sponsors

C

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Who Can Participate

Age: 50Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 50 years
  • Referral to a GCA clinic for suspected, new-onset Giant Cell Arteritis
  • Ability to understand and willingness to sign informed consent
  • Willingness to comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Referral for suspected GCA relapse
  • Use of systemic glucocorticoids for 14 or more consecutive days orally in the previous 30 days, or 7 or more days if intravenous glucocorticoids were given
  • Use of any conventional or biologic immunosuppressive therapy
  • History of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors, or conditions causing intracranial hypertension
  • Any condition preventing optic nerve sheath ultrasound or fundoscopy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

St-Joseph's Health Care London

London, Ontario, Canada, N6A 4V2

Not Yet Recruiting

2

Sinai Health - Toronto

Toronto, Ontario, Canada, M5G 1X5

Not Yet Recruiting

3

MUHC - McGill University

Montreal, Quebec, Canada, H3G 1A4

Not Yet Recruiting

4

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada, H4J1C5

Actively Recruiting

5

CIUSSS de l'Est-de-l'ile de Montreal

Montreal, Quebec, Canada, H4R 3K6

Not Yet Recruiting

6

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada, H1T 2M4

Not Yet Recruiting

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Research Team

J

Jean-Paul Makhzoum, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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