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NCT Number: NCT05749094

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

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?

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Key information

Conditions

Giant Cell Arteritis Anterior Ischemic Optic Neuropathy Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cranial Nerve Diseases Eye Diseases Immune System Diseases Nervous System Diseases Optic Nerve Diseases Optic Neuropathy, Ischemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St-Joseph's Health Care London, London, Ontario, Canada

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Diagnostic performance of ONSD to identify new-onset GCA

    Time frame: Baseline

    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.

  2. ONSD in patients with and without GCA

    Time frame: Baseline

    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.

Secondary outcomes

  1. ONSD changes over time

    Time frame: Up to 2 years

    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.

  2. The associations between ONSD changes and GCA relapses

    Time frame: Up to 2 years

    The association between ONSD changes and GCA relapses will be assessed during the follow-up period, in patients with GCA.

  3. Evaluation of the performance of ONSD to detect a GCA relapse

    Time frame: Up to 2 years

    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.

Other outcomes

  1. Intra- and Inter- observer reliability

    Time frame: Baseline

    Intra- and interobserver reliability of ONSD measurements

  2. Association between ONSD and Retinal Changes

    Time frame: Up to 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Paul Makhzoum, MD

CONTACT

[email protected]

5143382222 ext. 2725

Sponsors and collaborators

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Other

Collaborators

  • Ciusss de L'Est de l'Île de Montréal
  • Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Mount Sinai Hospital, Canada
  • Ottawa Hospital Research Institute
  • St. Joseph's Health Care London

Registry information

Official study title

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

Acronym: SONIC-GCA

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Mar 1, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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