[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552383":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":55,"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":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"discharge",null,"immediate discharge with ambulant HR monitoring (investigational treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room",[13],"Diagnostic Test: holter",{"label":15,"type":10,"description":16,"interventionNames":17},"admission for 24 hours with rhythmobservation","discharge after 24-hour telemetric-observation (reference treatment strategy) in low- and intermediate syncope patients in the setting of cardiac emergency room",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","holter","ambulant heart rate monitor (holter) for 24 hour.",[15,9],[25],{"name":26,"affiliation":27,"role":28},"Frederik de Lange, MD PhD","PI","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+31 (0) 20 5669111","f.j.delange@amsterdamumc.nl",{"name":35,"role":31,"phone":10,"phoneExt":10,"email":36},"Elise Hulsman, RN","e.l.hulsman@amsterdamumc.nl",[38],{"facility":39,"status":40,"city":41,"state":10,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Amsterdam UMC","RECRUITING","Amsterdam","1105 AZ","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.88969,52.37403,{"lat":49,"lon":48},[52,54],{"name":53,"role":31,"phone":10,"phoneExt":10,"email":33},"Frederik de Lange, MD, PhD",{"name":35,"role":31,"phone":10,"phoneExt":10,"email":36},{"type":28,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Frederik de Lange","principal investigator","100552383","in-hospital-24-hour-observation-of-syncope-patients-100552383",false,"NCT06472375","In Hospital 24 Hour Observation of Syncope Patients","Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room","RISC","Inclusion Criteria:\n\nAll patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.\n\nThe initial syncope evaluation includes:\n\n1. Complete and thorough history taking of the syncope event and past medical history\n2. Physical examination including supine and standing BP measurement and\n3. 12 lead ECG.\n\nExclusion Criteria:\n\nA potential patient who meets any of the following criteria will be excluded from participation in this study:\n\n1. Those aged \\\u003C18 years\n2. Those in whom syncope \u002F transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA\n3. Those with any other conditions then syncope \u002F transient loss of consciousness for which admission is required (including social indication for admission, etc.)\n4. Contraindication for early discharge as the discretion of the responsible physician\n5. Those with a learning disability\n6. Those presenting with pre-syncope\n7. Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)","ALL","18 Years",{"count":69,"type":70},640,"ESTIMATED","1 Month","OBSERVATIONAL","Syncope is very common and has a broad differential diagnosis. Guidelines on syncope recommend to apply guideline based syncope algorithm (SA) to identify low- \u002F intermediate risk syncope patients and recommend to discharge these patients. The time window when to discharge these patients is not defined in the guidelines. In current medical practice low- \u002F intermediate risk syncope patients are either immediately discharged or discharged after 24-hour observation with telemetry (TM). There seems to be an equipoise for both treatment strategies in current medical practice for these low risk syncope patients. A randomized controlled trial to compare discharge after 24 hour observation including TM with immediate discharge has never been done on the Cardiac Emergency Room (CER).",[75],"Syncope","2026-02-23",{"date":78,"type":79},"2026-02-24","ACTUAL",{"date":81,"type":79},"2023-11-17",{"date":83,"type":70},"2026-08-01",{"name":5,"class":6},1]