[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544754":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":10,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":10,"id":54,"slug":10,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Italian Society for Rheumatology","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 [APS]",null,"Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SN-APS)",[13],"Other: Diagnostic accuracy",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 [SN-APS]","Patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)",[13],{"label":19,"type":10,"description":20,"interventionNames":10},"Group 3 [Control Group]","Patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)",[22],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Diagnostic accuracy","To assess the diagnostic accuracy of non-criteria aPL (anti-vimentin\u002Fcardiolipin and anti-phosphatidylserine\u002Fprothrombin) in identifying APS in patients with thrombosis\u002F recurrent adverse pregnancy outcomes",[9,15],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Fabrizio Conti, MD","CONTACT","06 49974631","fabrizio.conti@uniroma1.it",{"name":33,"role":29,"phone":30,"phoneExt":10,"email":34},"Simona Truglia, MD","simona.truglia@uniroma1.it",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Umberto I Polyclinic, Rome- Department of Rheumatology","RECRUITING","Roma","Rome","00185","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],11.10642,44.99364,{"lat":48,"lon":47},[51],{"name":33,"role":29,"phone":30,"phoneExt":10,"email":34},{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100544754",false,"NCT06373003","Negative Antiphospholipid Syndrome: a Multicentric Study","INCLUSION CRITERIA:\n\n1. Group 1 \\[APS\\]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)\n2. Group 2 \\[SN-APS\\]: patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)\n3. Group 3: patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases).\n4. Age \\\u003C 65 years (at event time)\n5. Less than 5 years from the first even\n\nEXCLUSION CRITERIA\n\n1. Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations\n2. Deceased patients\n3. Less than 5 years from the first event","ALL","18 Years","65 Years",{"count":63,"type":64},105,"ESTIMATED","OBSERVATIONAL","Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.\n\nThe main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin\u002Fcardiolipin and anti-phosphatidylserine\u002Fprothrombin) in identifying APS in patients with thrombosis\u002Frecurrent adverse pregnancy outcomes.",[68,69],"Antiphospholipid Syndrome","Seronegative Antiphospholipid Syndrome","2025-05-09",{"date":72,"type":73},"2025-05-14","ACTUAL",{"date":75,"type":73},"2024-09-21",{"date":77,"type":64},"2026-09",{"name":5,"class":6},1]