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Recruiting NCT05749094

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

— Observational Giant Cell Arteritis Anterior Ischemic Optic Neuropathy Optic Neuropathy, Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic nerve sheath ultrasound, Standardized GCA assessment.
Who it may be relevant to
Registry conditions: Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy, Optic Neuropathy, Ischemic. Basic parameters: 50 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis

Overview

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?

Detailed description

SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).

Interventions

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

Primary outcome measures

  • Diagnostic performance of ONSD to identify new-onset GCA [Time frame: Baseline]
  • ONSD in patients with and without GCA [Time frame: Baseline]
Secondary outcome measures (3)
  • ONSD changes over time [Time frame: Up to 2 years]
  • The associations between ONSD changes and GCA relapses [Time frame: Up to 2 years]
  • Evaluation of the performance of ONSD to detect a GCA relapse [Time frame: Up to 2 years]

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:

  • 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.

Exclusion criteria

An individual who meets any of these criteria will be excluded from SONIC-GCA:

  • 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.
  • Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 6 centers
  • St-Joseph's Health Care London — London
  • Sinai Health - Toronto — Toronto
  • MUHC - McGill University — Montreal
  • Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal — Montreal
  • CIUSSS de l'Est-de-l'ile de Montreal — Montreal
  • CIUSSS de l'Estrie - CHUS — Sherbrooke

Identifiers

NCT: NCT05749094 · 20201890

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗