[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496811":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":129,"collaborators":132,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":10,"studyType":159,"phases":10,"briefSummary":160,"conditions":161,"keywords":10,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"GCA group",null,"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.\n\nStudy visits :\n\nBaseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)",[13,14],"Diagnostic Test: Optic nerve sheath ultrasound","Diagnostic Test: Standardized GCA assessment",{"label":16,"type":10,"description":17,"interventionNames":18},"Non-GCA group","Participants who do not meet the composite clinical test validation for GCA (above).\n\nStudy visits : Baseline and Month 6 (phone follow-up)",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","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.",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Standardized GCA assessment","Clinical assesment, blood test review, temporal\u002Faxillary artery ultrasound",[9,16],[30],{"name":31,"affiliation":32,"role":33},"Jean-Paul Makhzoum, MD","Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal","STUDY_CHAIR",[35],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","5143382222","2725","jean-paul.makhzoum@umontreal.ca",[41,60,74,89,104,115],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"St-Joseph's Health Care London","NOT_YET_RECRUITING","London","Ontario","N6A 4V2","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-81.23304,42.98339,{"lat":53,"lon":52},[56],{"name":57,"role":36,"phone":58,"phoneExt":10,"email":59},"Lillian Barra","519-646-6100","lillian.barra@sjhc.london.on.ca",{"facility":61,"status":43,"city":62,"state":45,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Sinai Health - Toronto","Toronto","M5G 1X5",{"type":50,"coordinates":65},[66,67],-79.39864,43.70643,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":72,"phoneExt":10,"email":73},"Christian Pagnoux","416-596-4200","Christian.pagnoux@sinaihealth.ca",{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"MUHC - McGill University","Montreal","Quebec","H3G 1A4",{"type":50,"coordinates":80},[81,82],-73.58781,45.50884,{"lat":82,"lon":81},[85],{"name":86,"role":36,"phone":87,"phoneExt":10,"email":88},"Arielle Mendel","4388556233","arielle.mendel@mcgill.ca",{"facility":90,"status":91,"city":76,"state":77,"zip":92,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal","RECRUITING","H4J1C5",{"type":50,"coordinates":94},[81,82],{"lat":82,"lon":81},[97,99,102],{"name":98,"role":36,"phone":10,"phoneExt":10,"email":39},"Jean-Paul Makhzoum, MD, MSc",{"name":100,"role":36,"phone":10,"phoneExt":10,"email":101},"Guylaine Marcotte","guylaine.marcotte.cnmtl@ssss.gouv.qc.ca",{"name":31,"role":103,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":105,"status":43,"city":76,"state":77,"zip":106,"country":47,"countryCode":48,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"CIUSSS de l'Est-de-l'ile de Montreal","H4R 3K6",{"type":50,"coordinates":108},[81,82],{"lat":82,"lon":81},[111],{"name":112,"role":36,"phone":113,"phoneExt":10,"email":114},"Roger Yang","514-252-3400","roger.yang.med@ssss.gouv.qc.ca",{"facility":116,"status":43,"city":117,"state":77,"zip":118,"country":47,"countryCode":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"CIUSSS de l'Estrie - CHUS","Sherbrooke","H1T 2M4",{"type":50,"coordinates":120},[121,122],-71.89908,45.40008,{"lat":122,"lon":121},[125],{"name":126,"role":36,"phone":127,"phoneExt":10,"email":128},"Patrick Liang","819-346-1110","rhumatoens-med@USherbrooke.ca",{"type":103,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jean-Paul Makhzoum","Director - Vasculitis Research Program, Principal Investigator",[133,135,137,139,141,143],{"name":134,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":136,"class":6},"Ciusss de L'Est de l'Île de Montréal",{"name":138,"class":6},"Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke",{"name":140,"class":6},"Mount Sinai Hospital, Canada",{"name":142,"class":6},"St. Joseph's Health Care London",{"name":144,"class":6},"Ottawa Hospital Research Institute","100496811","optic-nerve-sheath-ultrasound-in-giant-cell-arteritis-100496811",false,"NCT05749094","Optic Nerve Sheath Ultrasound in Giant Cell Arteritis","The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis","SONIC-GCA","Our population of interest is patients referred from any settings for suspected, new-onset GCA.\n\nInclusion criteria:\n\nTo be included in SONIC-GCA, participants must meet all the following criteria:\n\n1. Age \\> 50 years.\n2. Referral to a GCA clinic for suspected, new-onset GCA.\n3. Ability to understand and willingness to sign an informed consent form.\n4. Willingness to comply with study visits and procedures.\n\nExclusion criteria:\n\nAn individual who meets any of these criteria will be excluded from SONIC-GCA:\n\n1. Referral for a suspected GCA relapse.\n2. 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.\n3. Current use of any conventional or biologic immunosuppressive therapy.\n4. 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.\n5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.","ALL","50 Years","99 Years",{"count":157,"type":158},285,"ESTIMATED","OBSERVATIONAL","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:\n\n1. What is the performance of ONSD to identify patients with new-onset, active GCA?\n2. Is ONSD useful for monitoring GCA relapses during follow-up?\n3. What is the intra- and interobserver reliability of ONSD measurements?\n4. Does ONSD differ between patients with and without GCA-related retinal findings?",[162,163,164],"Giant Cell Arteritis","Anterior Ischemic Optic Neuropathy","Optic Neuropathy, Ischemic","2025-08-02",{"date":167,"type":168},"2025-08-07","ACTUAL",{"date":170,"type":158},"2025-08",{"date":172,"type":158},"2029-03",{"name":5,"class":6},6]