[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457593":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":49,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: intervention group",null,"This group will receive PFO-closure and standard antiplatelet treatment PFO-closure will be performed after 3-6 months of observation and monitoring for paroxysmal atrial fibrillation Standard antiplatelet treatment will be prescribed - aspirin 100mg and clopidogrel 75mg, once daily, principally. However, the final decision of antiplatelet treatment will be made by the physician. If paroxysmal atrial fibrillation is detected, anticoagulation will be considered.\n\nIntervention : PFO closure Drug: aspirin 100mg\u002Fday Drug: clopidogrel 75mg\u002Fday",[13],"Procedure: PFO closure",{"label":15,"type":10,"description":16,"interventionNames":10},"Active comparator: control group","This group will receive standard antiplatelet treatment only Dual antiplatelet treatment with Aspirin 100mg and Clopidogrel 75mg, once daily, or single antiplatelet treatment with those agents can be considered. If paroxysmal atrial fibrillation is detected, anticoagulation will be considered.\n\nDrug: aspirin 100mg\u002Fday Drug: clopidogrel 75mg\u002Fday",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","PFO closure","PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Sun U Kwon, MD. PhD","CONTACT","82-2-3010-3960","sukwon@amc.seoul.kr",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Bum Joon Kim, MD PhD","82-2-3010-3981","bj.kim@amc.seoul.kr",[34],{"facility":5,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":10,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Seoul","05055","South Korea",{"type":40,"coordinates":41},"Point",[42,43],126.9784,37.566,{"lat":43,"lon":42},[46],{"name":47,"role":26,"phone":48,"phoneExt":10,"email":28},"Sun U Kwon, MD PhD","02-3010-3960",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Sun U. Kwon","Professor",[54],{"name":55,"class":56},"National Evidence-Based Healthcare Collaborating Agency","OTHER_GOV","100457593","prospective-registry-of-elderly-esus-with-pfo-100457593",false,"NCT05238610","Prospective Registry of Elderly ESUS With PFO","Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale","COACH_ESUS","Inclusion Criteria:\n\n1. Patients older than 60 years-old\n2. Patients diagnosed as ESUS within 180 days from onset\n3. PFO found from TTE or TEE, which attributed to the ischemic stroke\n4. Patients or their legal representative agreed to participate\n\nExclusion Criteria:\n\n1. Patients with transient ischemic attack\n2. Patients with ischemic stroke at the vascular territory with significant stenosis\n3. Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography\n4. Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)\n5. Patients with active cancer\n6. Patients who need long term anticoagulation\n7. Patients who have side effect on antiplatelet treatment\n8. Patients with active internal bleeding\n9. Patients who refuse to participate","ALL","60 Years",{"count":68,"type":69},1200,"ESTIMATED","1 Year","OBSERVATIONAL","Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years",[74],"Embolic Stroke of Undetermined Source",[76,77,78,79],"insertable loop recorder","patent foramen ovale","patent foramen ovale closure","elderly","2022-02-11",{"date":82,"type":83},"2022-02-14","ACTUAL",{"date":85,"type":83},"2022-01-17",{"date":87,"type":69},"2027-05-31",{"name":5,"class":6},1]