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NCT05749094 | NOT YET RECRUITING | Giant Cell Arteritis

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Sponsor:

Sacre-Coeur Hospital of Montreal

Information provided by (Responsible Party):

Makhzum jackfruit

Brief Summary:

The Sonographic Assessment of the Optic Nerve Sheath in GCA (SONIC-GCA) study will: 1) assess the performance, in terms of sensitivity and specificity, of the optic nerve sheath diameter (ONSD) to detect new-onset, active GCA; 2) evaluate the intra- and interobserver reliability of ONSD measures; 3) establish if an association exists between the ONSD and the presence of GCA retinal findings; and 4) evaluate if the ONSD is a dynamic biomarker of GCA remission and relapse.

Condition or disease

Giant Cell Arteritis

Anterior Ischemic Optic Neuropathy

Optic Neuropathy, Ischemic

Intervention/treatment

Optic nerve sheath ultrasound

Standardized GCA assessment

Detailed Description:

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 260 participants
Official Title : The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2029-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 99 Years
Sexes Eligible for Study: ALL
Criteria
Inclusion criteria are
  • 1. adult patient aged \> 50 years;
  • 2. referred for suspected, new-onset cranial GCA;
  • 3. ability to understand and provide a written informed consent.
  • Exclusion criteria
    • 1. referral for a suspected GCA relapse;
    • 2. current use of systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days;
    • 3. known previous medical history of conditions which may affect the ONSD, such as optic nerve diseases, demyelinating diseases, or any conditions associated with intracranial hypertension;
    • 4. known underlying condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Location Details

NCT05749094

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Quebec

Vasculitis Clinic, Sacre-Coeur Hospital of Montreal

Montreal, Quebec, Canada, H4J1C5