Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-99
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
About this trial
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
Qualifiers
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.
Disqualifiers
Referral for a suspected GCA relapse.
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.
Current use of any conventional or biologic immunosuppressive therapy.
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.
Trial design
Treatments tested in this trial
- Optic nerve sheath ultrasound
- Standardized GCA assessment
Treatment groups
285 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Ciusss de L'Est de l'Île de Montréal
Collaborator
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Collaborator
Mount Sinai Hospital, Canada
Collaborator
St. Joseph's Health Care London
Collaborator
Ottawa Hospital Research Institute
Collaborator
Source ClinicalTrials.gov