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| Name | Class |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Ciusss de L'Est de l'Île de Montréal | OTHER |
| Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke |
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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:
SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCA group | 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) |
| |
| Non-GCA group | Participants who do not meet the composite clinical test validation for GCA (above). Study visits : Baseline and Month 6 (phone follow-up) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optic nerve sheath ultrasound | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of ONSD to identify new-onset GCA | The primary outcome of SONIC-GCA is to determine the optimal ONSD cutoff for identifying GCA at the baseline visit and to assess its diagnostic performance, including sensitivity, specificity, positive and negative predictive values, and accuracy. | Baseline |
| ONSD in patients with and without GCA | At baseline, ONSD measurements (in mm) of the left and right eyes of each participant will be recorded and used to calculate the mean ONSD for patients with and without GCA. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| ONSD changes over time | The main secondary outcome will determine whether ONSD dynamically correlates with relapse risk over the follow-up period in patients with GCA, providing insight into its potential as a biomarker for disease monitoring. | Up to 2 years |
| The associations between ONSD changes and GCA relapses |
| Measure | Description | Time Frame |
|---|---|---|
| Intra- and Inter- observer reliability | Intra- and interobserver reliability of ONSD measurements | Baseline |
| Association between ONSD and Retinal Changes | The association between ONSD and the presence/absence of GCA-related retinal findings on digital fundoscopy in patients with GCA. |
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:
Exclusion criteria:
An individual who meets any of these criteria will be excluded from SONIC-GCA:
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Consecutive participants referred for suspected new-onset GCA.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Paul Makhzoum, MD | Contact | 5143382222 | 2725 | jean-paul.makhzoum@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Makhzoum, MD | Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St-Joseph's Health Care London | Not yet recruiting | London | Ontario | N6A 4V2 | Canada |
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| Label | URL |
|---|---|
| Vasculitis Clinic - University of Montreal | View source |
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| Mount Sinai Hospital, Canada | OTHER |
| St. Joseph's Health Care London | OTHER |
| Ottawa Hospital Research Institute | OTHER |
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|
| Standardized GCA assessment | Diagnostic Test | Clinical assesment, blood test review, temporal/axillary artery ultrasound |
|
The association between ONSD changes and GCA relapses will be assessed during the follow-up period, in patients with GCA. |
| Up to 2 years |
| Evaluation of the performance of ONSD to detect a GCA relapse | We will assess the diagnostic performance of the initial ONSD cutoff (from the primary objective) at each follow-up visit to differentiate between relapse and remission. This analysis will determine whether the established cutoff remains a reliable marker for monitoring disease status in GCA over time. | Up to 2 years |
| Up to 2 years |
| Sinai Health - Toronto | Not yet recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| MUHC - McGill University | Not yet recruiting | Montreal | Quebec | H3G 1A4 | Canada |
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| Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal | Recruiting | Montreal | Quebec | H4J1C5 | Canada |
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| CIUSSS de l'Est-de-l'ile de Montreal | Not yet recruiting | Montreal | Quebec | H4R 3K6 | Canada |
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| CIUSSS de l'Estrie - CHUS | Not yet recruiting | Sherbrooke | Quebec | H1T 2M4 | Canada |
|
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| D018917 | Optic Neuropathy, Ischemic |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
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