Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

ConditionsGiant Cell Arteritis Anterior Ischemic Optic Neuropathy Optic Neuropathy, Ischemic

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

This trial does not accept healthy volunteers

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 population

Consecutive participants referred for suspected new-onset GCA.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Optic nerve sheath ultrasound
Diagnostic test
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.
Standardized GCA assessment
Diagnostic test
Clinical assesment, blood test review, temporal/axillary artery ultrasound

Treatment groups

285 Participants

are divided into 2 treatment groups

Group A: GCA group2 interventions

Group B: Non-GCA group2 interventions

Trial outcomes

Primary outcomes

Diagnostic 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

Secondary outcomes

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

Other outcomes

Intra- and Inter- observer reliability

Intra- and interobserver reliability of ONSD measurements

Time frame

Baseline

Association between ONSD and Retinal Changes

The association between ONSD and the presence/absence of GCA-related retinal findings on digital fundoscopy in patients with GCA.

Time frame

Up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Apply now