Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
285 participants
OBSERVATIONAL
2025-08-31
2029-03-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
Optic nerve sheath ultrasound
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.
Standardized GCA assessment
Clinical assesment, blood test review, temporal/axillary artery ultrasound
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)
Optic nerve sheath ultrasound
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.
Standardized GCA assessment
Clinical assesment, blood test review, temporal/axillary artery ultrasound
Interventions
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Optic nerve sheath ultrasound
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.
Standardized GCA assessment
Clinical assesment, blood test review, temporal/axillary artery ultrasound
Eligibility Criteria
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Inclusion 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
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.
50 Years
99 Years
ALL
No
Sponsors
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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
OTHER
Mount Sinai Hospital, Canada
OTHER
St. Joseph's Health Care London
OTHER
Ottawa Hospital Research Institute
OTHER
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
OTHER
Responsible Party
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Jean-Paul Makhzoum
Director - Vasculitis Research Program, Principal Investigator
Principal Investigators
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Jean-Paul Makhzoum, MD
Role: STUDY_CHAIR
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
Locations
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St-Joseph's Health Care London
London, Ontario, Canada
Sinai Health - Toronto
Toronto, Ontario, Canada
MUHC - McGill University
Montreal, Quebec, Canada
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
CIUSSS de l'Est-de-l'ile de Montreal
Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Vasculitis Clinic - University of Montreal
Other Identifiers
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20201890
Identifier Type: -
Identifier Source: org_study_id
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