Optic Nerve Sheath Ultrasound in Giant Cell Arteritis (SONIC-GCA)

Montreal Sacred Heart Hospital

Status: Begins enrollment in 1 month

Conditions: Giant Cell Arteritis; Optic Neuropathy, Ischemic; Anterior Ischemic Optic Neuropathy

Treatments: Diagnostic Test: Optic nerve sheath ultrasound; Diagnostic Test: Standardized GCA assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05749094

20201890

Details and patient eligibility

About

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.

Full description

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

Enrollment: 260 estimated patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

260 participants in 2 patient groups

GCA group

Description:

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.

Treatment:

Diagnostic Test: Standardized GCA assessment

Diagnostic Test: Optic nerve sheath ultrasound

Non-GCA group

Description:

Participants who do not meet the composite clinical test validation for GCA (above).

Treatment:

Diagnostic Test: Standardized GCA assessment

Diagnostic Test: Optic nerve sheath ultrasound