NCT05749094

Brief Summary

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. 1.What is the performance of ONSD to identify patients with new-onset, active GCA?
  2. 2.Is ONSD useful for monitoring GCA relapses during follow-up?
  3. 3.What is the intra- and interobserver reliability of ONSD measurements?
  4. 4.Does ONSD differ between patients with and without GCA-related retinal findings?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Aug 2025Mar 2029

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

February 18, 2023

Last Update Submit

August 2, 2025

Conditions

Giant Cell ArteritisAnterior Ischemic Optic NeuropathyOptic Neuropathy, Ischemic

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Secondary Outcomes (3)

  • ONSD changes over time

    Up to 2 years

  • The associations between ONSD changes and GCA relapses

    Up to 2 years

  • Evaluation of the performance of ONSD to detect a GCA relapse

    Up to 2 years

Other Outcomes (2)

  • Intra- and Inter- observer reliability

    Baseline

  • Association between ONSD and Retinal Changes

    Up to 2 years

Study Arms (2)

GCA group

Ascertainment of GCA will occur 6 months after study inclusion and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive diagnostic test for GCA, including ultrasound of temporal arteries, temporal artery biopsy, cranial MRI or cranial PET; and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA. Study visits : Baseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)

Diagnostic Test: Optic nerve sheath ultrasoundDiagnostic Test: Standardized GCA assessment

Non-GCA group

Participants who do not meet the composite clinical test validation for GCA (above). Study visits : Baseline and Month 6 (phone follow-up)

Diagnostic Test: Optic nerve sheath ultrasoundDiagnostic Test: Standardized GCA assessment

Interventions

Optic nerve sheath ultrasoundDIAGNOSTIC_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.

GCA groupNon-GCA group
Standardized GCA assessmentDIAGNOSTIC_TEST

Clinical assesment, blood test review, temporal/axillary artery ultrasound

GCA groupNon-GCA group

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive participants referred for suspected new-onset GCA.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St-Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

NOT YET RECRUITING

Sinai Health - Toronto

Toronto, Ontario, M5G 1X5, Canada

NOT YET RECRUITING

MUHC - McGill University

Montreal, Quebec, H3G 1A4, Canada

NOT YET RECRUITING

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

RECRUITING

CIUSSS de l'Est-de-l'ile de Montreal

Montreal, Quebec, H4R 3K6, Canada

NOT YET RECRUITING

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, H1T 2M4, Canada

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Giant Cell ArteritisOptic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Jean-Paul Makhzoum, MD

    Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal

    STUDY CHAIR

Central Study Contacts

Jean-Paul Makhzoum, MD

CONTACT

5143382222jean-paul.makhzoum@umontreal.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - Vasculitis Research Program, Principal Investigator

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

August 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)