Optic nerve sheath ultrasound to diagnose and monitor giant cell arteritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SONIC-GCA is a prospective cohort and validation study carried out across Canadian Vasculitis Research Network centers. It uses standardized optic nerve sheath diameter (ONSD) measurements by ultrasound at baseline and during follow-up to identify active new-onset GCA and to detect relapses. The study will compare ONSD findings with clinical diagnoses and retinal findings, and will quantify intra- and interobserver reliability of the ultrasound measurements. Patients on prolonged systemic glucocorticoids, on immunosuppressive therapy, or with prior retinal or optic nerve disease are excluded to limit confounding.

Why it matters

Who can join: the full rules

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:

1. Age \> 50 years.
2. Referral to a GCA clinic for suspected, new-onset GCA.
3. Ability to understand and willingness to sign an informed consent form.
4. Willingness to comply with study visits and procedures.

Exclusion criteria:

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

1. Referral for a suspected GCA relapse.
2. 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.
3. Current use of any conventional or biologic immunosuppressive therapy.
4. 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.
5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.

Where it's running

• Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
  Montreal, Quebec, Canada Recruiting
• St-Joseph's Health Care London
  London, Ontario, Canada Not yet recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Not yet recruiting
• Sinai Health - Toronto
  Toronto, Ontario, Canada Not yet recruiting
• MUHC - McGill University
  Montreal, Quebec, Canada Not yet recruiting
• CIUSSS de l'Est-de-l'ile de Montreal
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Study coordinator: Jean-Paul Makhzoum, MD
• Email: jean-paul.makhzoum@umontreal.ca
• Phone: 5143382222

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding how Giant Cell Arteritis affects vision

  This study is trying to understand how Giant Cell Arteritis affects vision in adults by comparing eye health in those with GCA-related vision problems to those with other causes of vision loss.

  Recruiting ASST Fatebenefratelli Sacco · Milan, Lombardy · NCT06500728

• How optic nerve swelling changes after starting steroids in giant cell arteritis

  This study tests how quickly the optic nerve sheath swelling decreases after starting glucocorticoids in people with newly diagnosed giant cell arteritis.

  Recruiting Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Montreal, Quebec · NCT07508514

• Precision care for giant cell arteritis and polymyalgia rheumatica

  This long-term observational project will follow adults with giant cell arteritis or polymyalgia rheumatica to see if regular imaging, eye exams, blood tests, and immune cell profiling can better predict aortic complications and steroid side effects over 5–10 years.

  Recruiting Wuerzburg University Hospital · Würzburg · NCT07084480

• Ultrasound lesions in temporal and axillary arteries and relapse risk in giant cell arteritis.

  We will test whether lesions seen on ultrasound of the temporal and axillary arteries can predict relapse in people with giant cell arteritis.

  Recruiting at 2 sites University Hospital, Brest · Brest and 1 other locations · NCT06894602

• Understanding biomarkers in giant cell arteritis and polymyalgia rheumatica

  This study is trying to find specific markers in the blood of people newly diagnosed with giant cell arteritis and polymyalgia rheumatica to help doctors understand their disease better and create personalized treatment plans.

  Recruiting University of Bonn · Bonn, North Rhine-Westphalia · NCT06460142

• Investigating a new imaging tracer for diagnosing giant cell arteritis

  This study is testing a new imaging method called AzaFol-PET/CT to see if it can better diagnose giant cell arteritis in people aged 50 and older compared to the current standard method.

  Recruiting Phase 2 Insel Gruppe AG, University Hospital Bern · Bern · NCT06335888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.