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?
SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).
Study Type
OBSERVATIONAL
Enrollment
285
The patients are examined in a supine relaxed position. The probe is gently placed on the closed eyelid with a standard ultrasound gel and adjusted to a suitable angle to display the optic nerve entry into the eyeball. Measurements are done 3mm distal to the posterior aspect of the ocular globe. Ultrasosonographic 14L5 probe is used with a safe thermal index, mechanical index and intensity limit. All patients will also undergo a bedside fundoscopic examination. Official ophthalmology consultation will be requested in patients with visual symptoms or abnormal fundoscopy.
Clinical assesment, blood test review, temporal/axillary artery ultrasound
St-Joseph's Health Care London
London, Ontario, Canada
NOT_YET_RECRUITINGSinai Health - Toronto
Toronto, Ontario, Canada
NOT_YET_RECRUITINGMUHC - McGill University
Montreal, Quebec, Canada
NOT_YET_RECRUITINGVasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
RECRUITINGCIUSSS de l'Est-de-l'ile de Montreal
Montreal, Quebec, Canada
NOT_YET_RECRUITINGCIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
NOT_YET_RECRUITINGDiagnostic performance of ONSD to identify new-onset GCA
The primary outcome of SONIC-GCA is to determine the optimal ONSD cutoff for identifying GCA at the baseline visit and to assess its diagnostic performance, including sensitivity, specificity, positive and negative predictive values, and accuracy.
Time frame: Baseline
ONSD in patients with and without GCA
At baseline, ONSD measurements (in mm) of the left and right eyes of each participant will be recorded and used to calculate the mean ONSD for patients with and without GCA.
Time frame: Baseline
ONSD changes over time
The main secondary outcome will determine whether ONSD dynamically correlates with relapse risk over the follow-up period in patients with GCA, providing insight into its potential as a biomarker for disease monitoring.
Time frame: Up to 2 years
The associations between ONSD changes and GCA relapses
The association between ONSD changes and GCA relapses will be assessed during the follow-up period, in patients with GCA.
Time frame: Up to 2 years
Evaluation of the performance of ONSD to detect a GCA relapse
We will assess the diagnostic performance of the initial ONSD cutoff (from the primary objective) at each follow-up visit to differentiate between relapse and remission. This analysis will determine whether the established cutoff remains a reliable marker for monitoring disease status in GCA over time.
Time frame: Up to 2 years
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