[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"temporal-arteritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:temporal-arteritis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},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.",[25,26,27,28],"Giant Cell Arteritis","Temporal Arteritis","Optic Nerve Diseases","Diagnosis","NOT_YET_RECRUITING","2026-03-31",{"date":32,"type":33},"2026-04-02","ACTUAL",{"date":35,"type":21},"2026-05-01",{"date":37,"type":21},"2028-05-01",{"name":39,"class":40},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100534841","clonal-hematopoiesis-in-giant-cell-arteritis-100534841","NCT06244069","Clonal Hematopoiesis in Giant Cell Arteritis","CH-GCA","Inclusion Criteria:\n\n* Patients with suspected active GCA entering into a fast-track work-up and healthy matched controls.\n* Capability of providing valid consent to study enrollment.\n* Possibility of performing temporal artery biopsy within three hours from enrollment.\n\nExclusion Criteria:\n\n* Active concurrent viral, fungal or bacterial infections (including active\u002Flatent tuberculosis treated for less than 4 weeks, HIV and Hepatitis B\u002FC virus (HBV\u002FHCV) infections.\n* Concurrent systemic inflammation not attributable to GCA (inflammatory diseases in treatment-free remission are accepted).\n* Use of other immunosuppressive agents in the last 3 months.\n* Use of systemic steroids (any dose in the last week, \\> 15 mg\u002Fdie of prednisone equivalent in the last month).\n* Solid or hematologic malignancies (active or with less than 6 months free of disease or antiblastic chemotherapy (hormone therapy is allowed).\n* Previous solid or hematopoietic stem cell transplantation (corneal transplants are allowed).\n* Any systemic immunosuppressive or steroidal therapy.\n* Chronic renal failure with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin \\*1.73 m2.\n* Moderate-severe liver failure (Child-Pugh B or C), hepatitis in stages of activity.\n* Diabetes mellitus.\n* Heart failure with New York Heart Association score (NYHA) \\>=2.\n* Severe hypoproteinemia\u002Fmalnutrition.\n* Chronic respiratory failure requiring O2 therapy or ventilation therapy at home.\n* Any other condition judged by the local investigator as a contra-indication to eligibility.",true,"18 Years",{"count":52,"type":21},326,"The goal of this clinical trial is to verify whether CHIP is correlated with the clinical, instrumental, and histological characteristics of GCA, and to characterize the pathogenetic effects of clonal hemopoiesis on vasculitis. The main objective of this study is to verify if clonal hematopoiesis of indeterminate potential (CHIP) affects GCA manifestations, course\u002Fresponse to therapies, and pathogenesis.\n\nPatients who are going to be diagnosed with GCA and for which a fast track is available for a rapid diagnostic work-up including pre-treatment temporal artery biopsy. Patients with CHIP will be identified and characterized by using whole exome sequencing from the peripheral blood samples. The presence and characteristics of CHIP will be correlated with baseline clinical, instrumental, and histologic GCA features.",[25,26,55,56,57],"Clonal Hematopoiesis of Indeterminate Potential","Horton Disease","Systemic Vasculitis Primary",[59,60,55,61,62,63,64],"Temporal artery biopsy","Giant cell arteritis","Single cell transcriptomics","Large vessels vasculitis","Horton disease","Whole Exome Sequencing","2024-02-02",{"date":67,"type":33},"2024-02-06",{"date":69,"type":21},"2024-03",{"date":71,"type":21},"2031-03",{"name":73,"class":40},"ASST Fatebenefratelli Sacco"]