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

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status: Enrolling

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 Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions:

1. What is the performance of ONSD to identify patients with new-onset, active GCA?
2. Is ONSD useful for monitoring GCA relapses during follow-up?
3. What is the intra- and interobserver reliability of ONSD measurements?
4. Does ONSD differ between patients with and without GCA-related retinal findings?

Full description

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

Enrollment: 285 estimated patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

285 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. Study visits : Baseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)

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). Study visits : Baseline and Month 6 (phone follow-up)

Treatment:

Diagnostic Test: Standardized GCA assessment

Diagnostic Test: Optic nerve sheath ultrasound