NCT05749094 Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
| NCT ID | NCT05749094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
| Condition | Giant Cell Arteritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 285 participants |
| Start Date | 2025-08 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 285 participants in total. It began in 2025-08 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Our population of interest is patients referred from any settings for suspected, new-onset GCA. Inclusion criteria: To be included in SONIC-GCA, participants must meet all the following criteria: 1. Age \> 50 years. 2. Referral to a GCA clinic for suspected, new-onset GCA. 3. Ability to understand and willingness to sign an informed consent form. 4. Willingness to comply with study visits and procedures. Exclusion criteria: An individual who meets any of these criteria will be excluded from SONIC-GCA: 1. Referral for a suspected GCA relapse. 2. Current use of systemic glucocorticoids, with the following duration at the baseline visit: ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days. 3. Current use of any conventional or biologic immunosuppressive therapy. 4. Known previous medical history of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors (benign or malignant), or any conditions associated with intracranial hypertension. 5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
Contact & Investigator
Jean-Paul Makhzoum, MD
STUDY CHAIR
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
Frequently Asked Questions
Who can join the NCT05749094 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 99 Years, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05749094 currently recruiting?
Yes, NCT05749094 is actively recruiting participants. Contact the research team at jean-paul.makhzoum@umontreal.ca for enrollment information.
Where is the NCT05749094 trial being conducted?
This trial is being conducted at London, Canada, Toronto, Canada, Montreal, Canada, Montreal, Canada and 2 additional locations.
Who is sponsoring the NCT05749094 clinical trial?
NCT05749094 is sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. The principal investigator is Jean-Paul Makhzoum, MD at Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal. The trial plans to enroll 285 participants.