Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

— ONS-GCA  

Official title:

Optic Nerve Sheath Ultrasound as a Predictor and Biomarker in Giant Cell Arteritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05749094
• Other study ID #: 20201890
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: August 2027

Study information

• Verified date: September 2023
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: Jean-Paul Makhzoum, MD
• Phone: 5143382222
• Email: jean-paul.makhzoum[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this observational cohort study are :

1. To assess the ability of optic nerve (ON), optic nerve sheath diameter (ONSD) and optic nerve sheath thickness (ONST) measured by ultrasound to predict Giant Cell Arteritis.

2. To evaluate changes in ON, ONSD, ONST measurements in patients with confirmed GCA after three months of therapy

3. To assess dynamic changes in ON, ONSD, ONST measurements in patients with relapsing GCA

Description:

Giant Cell Arteritis is the most common primary vasculitis in adult patients. GCA is difficult to diagnose, and no single test allows perfect classification of GCA. Imaging in GCA such as high resolution ultrasound is gaining populatity and allows identification of patients that would have been otherwise missed.

Recently, optic nerve sheath enhancement on MRI has been described and associated with the presence of GCA. Evaluation of the optic nerve and optic nerve sheath using ultrasound is easy to perform but has never been assessed in GCA.

Objectives:

1. To assess the ability of optic nerve (ON), optic nerve sheath diameter (ONSD) and optic nerve sheath thickness (ONST) measured by ultrasound to predict Giant Cell Arteritis.

2. To evaluate changes in ON, ONSD, ONST measurements in patients with confirmed GCA after three months of therapy

3. To assess dynamic changes in ON, ONSD, ONST measurements in patients with relapsing GCA

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2027
• Est. primary completion date: August 2025
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• Adult patients referred to our fast-track vasculitis clinic with a clinical suspicion of new-onset GCA.

• Must have a duration of glucocorticoid treatment of less than 14 days.

• Must sign informed consent

• Participation must be able to attend a 3 month follow-up visit, and in those with GCA, longitudinal clinic visits

Exclusion Criteria:

• Chronic use of immunosupressive therapy or glucocorticoids for more than 14 days

• Pre-existing known retinal or optic nerve disease

Related Conditions & MeSH terms

• Anterior Ischemic Optic Neuropathy
• Arteritis
• Giant Cell Arteritis
• Ischemia
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Polymyalgia Rheumatica

Intervention

Diagnostic Test:
• Optic nerve 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 consultation will be requested in patients with visual symptoms or abnormal fundoscopy.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de Lanaudiere	Joliette	Quebec
Canada	Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Hopital Laurentien	Sainte-Agathe-des-Monts	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of ON, ONSD, ONDT measurements in participants with and without GCA		Baseline
Secondary	In participants with GCA, evaluate ON, ONSD, ONDT measurement changes while on therapy.		3 months after baseline visit
Secondary	In participants with suspected GCA relapse, evaluate ON, ONSD, ONDT measurement changes		From month 3 to month 24 (following baseline visit)

External Links

•   Vasculitis Clinic - University of Montreal