[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632040":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":54,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GCA group",null,"Patients with new-onset GCA who completed the SONIC-GCA (main study) baseline visit and who received 48 hours or less of glucocorticoids and less or equal to 160mg of oral prednisone equivalent.\n\nStudy visits : Baseline, then days 3, 7, 10, 14, 21, 28, and Month 2",[13,14,15],"Diagnostic Test: Optic Nerve Sheath Ultrasound","Diagnostic Test: Temporal artery ultrasound","Diagnostic Test: Bloodwork : CRP and ESR",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DIAGNOSTIC_TEST","Optic Nerve Sheath Ultrasound","Optic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Temporal artery ultrasound","With measurement of the intima-media complex and calculation of the OGUS.",[9],{"type":18,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Bloodwork : CRP and ESR","At each visit",[9],[31],{"name":32,"affiliation":33,"role":34},"Jean-Paul Makhzoum, MD, MSc","CISSS du Nord-de-l'ile de Montreal","STUDY_CHAIR",[36],{"name":32,"role":37,"phone":38,"phoneExt":10,"email":39},"CONTACT","514-338-2222","jean-paul.makhzoum@umontreal.ca",[41],{"facility":42,"status":10,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":10},"Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal","Montreal","Quebec","H4J1C5","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-73.58781,45.50884,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Jean-Paul Makhzoum","Clinician-Scientist","100632040","early-temporal-dynamics-of-optic-nerve-sheath-diameter-after-therapy-in-gca-100632040",false,"NCT07508514","Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA","Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis","SONIC-TIME","Inclusion Criteria:\n\n1. Participants must be enrolled in SONIC-GCA and must have:\n\n   * completed the baseline optic nerve sheath ultrasound\n   * confirmed GCA as determined by the baseline standardized GCA assessment in SONIC-GCA.\n2. Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.\n3. Ability and willingness to provide written informed consent.\n4. Agreement to complete the SONIC-TIME intensive follow-up schedule.\n\nExclusion Criteria:\n\n1\\) Concurrent participation in a blinded interventional pharmaceutical clinical trial.","ALL","50 Years",{"count":69,"type":70},60,"ESTIMATED","OBSERVATIONAL","Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. The optic nerve sheath diameter (ONSD), measurable by ocular ultrasound, reflects perineural edema and may serve as a quantitative biomarker of ocular inflammation in GCA.\n\nThe SONIC-TIME study (Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis) is a single-center, prospective observational substudy embedded within SONIC-GCA (NCT05749094) at Hôpital du Sacré-Cœur de Montréal. It aims to characterize how rapidly ONSD decreases after GC initiation and how this trajectory relates to cumulative GC exposure, intravenous methylprednisolone, and early use of steroid-sparing therapies.\n\nSixty participants with newly diagnosed GCA will undergo serial optic nerve sheath ultrasound, blood tests (CRP, ESR), and when feasible, temporal artery ultrasound over the first two months of therapy (Days 3, 7, 10, 14, 21, 28, and Month 2). No experimental treatments are given; all participants receive standard-of-care therapy.\n\nThe primary objective is to quantify the percent change in mean ONSD from baseline to Day 28. Secondary objectives include modeling ONSD change over time, assessing associations with cumulative steroid dose and inflammatory markers, and estimating the time to normalization below the SONIC-GCA cutoff. Findings will define the optimal imaging window and refine the diagnostic and monitoring role of optic nerve ultrasound in GCA.",[74,75,76,77],"Giant Cell Arteritis","Temporal Arteritis","Optic Nerve Diseases","Diagnosis","NOT_YET_RECRUITING","2026-03-31",{"date":81,"type":82},"2026-04-02","ACTUAL",{"date":84,"type":70},"2026-05-01",{"date":86,"type":70},"2028-05-01",{"name":5,"class":6},1]