ONS-GCA: Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Sponsor

Hopital du Sacre-Coeur de Montreal (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05749094

Collaborator

(none)

300

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this observational cohort study are :

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

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Arteritis Anterior Ischemic Optic Neuropathy Optic Neuropathy, Ischemic	Diagnostic Test: Optic nerve ultrasound

Detailed 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:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2027

Outcome Measures

Primary Outcome Measures

Comparison of ON, ONSD, ONDT measurements in participants with and without GCA [Baseline]

Secondary Outcome Measures

In participants with GCA, evaluate ON, ONSD, ONDT measurement changes while on therapy. [3 months after baseline visit]
In participants with suspected GCA relapse, evaluate ON, ONSD, ONDT measurement changes [From month 3 to month 24 (following baseline visit)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 95 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de Lanaudiere	Joliette	Quebec	Canada	J6E 6J2
2	Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal	Montreal	Quebec	Canada	H4J1C5
3	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec	Canada	H2X 0C1
4	Hopital Laurentien	Sainte-Agathe-des-Monts	Quebec	Canada	J8C 2B8