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Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Study acronym: SONIC-GCA
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 9 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 260 to 285
    • Study sites: 1 to 6
    • Primary completion date: Oct 2027 to Dec 2027
    • Study completion date: Feb 2029 to Mar 2029
    • Start date: Jul 2025 to Aug 2025
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints: 2 to 3
    • Collaborators expanded, about 44 words
  2. Primary completion date: Aug 2025 to Oct 2027v3 Show 10 more changesShow less
    • Start date: Mar 2024 to Jul 2025
    • Primary endpoint revised
    • Enrollment target: 300 to 260
    • Study sites: 4 to 1
    • Study completion date: Aug 2027 to Feb 2029
    • Interventions: Optic nerve ultrasound (Diagnostic Test) to Optic nerve sheath ultrasound (Diagnostic Test), Standardized GCA assessment (Diagnostic Test)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (2)
    • Study description shortened, about 129 words
    • Study arms: 0 to 2
  3. Start date: Jun 2023 to Mar 2024v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05749094
Lead Sponsor Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre, Ciusss de L'Est de l'Île de Montréal, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke, Mount Sinai Hospital, Canada, St. Joseph's Health Care London, Ottawa Hospital Research Institute
Conditions
(from sponsor)		 Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy, Optic Neuropathy, Ischemic
Related terms Giant Cell Arteritis, Optic Neuropathy, Ischemic
Enrollment 285 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov