Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04285918
Status:
UNKNOWN
Last Update Posted:
2020-02-26
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2024-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months', 'timeFrame': 'Enrollment to 6 months', 'description': 'Paroxysmal AF episodes \\> 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months'}], 'secondaryOutcomes': [{'measure': 'Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 36 months', 'timeFrame': 'Enrollment to 36 months', 'description': 'Paroxysmal AF episodes \\> 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 36 months'}, {'measure': 'Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months', 'timeFrame': '6 months to 36 months', 'description': 'Paroxysmal AF episodes \\> 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months'}, {'measure': 'Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)', 'timeFrame': 'Enrollment to 36 months', 'description': 'Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)'}, {'measure': 'Recurrent stroke or TIA', 'timeFrame': 'Enrollment to 36 months', 'description': 'Recurrent stroke or TIA'}, {'measure': 'All-cause death, Vascular Death', 'timeFrame': 'Enrollment to 36 months', 'description': 'All-cause death, Vascular Death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cryptogenic Stroke', 'High Risk Patent Foramen Ovale']}, 'descriptionModule': {'briefSummary': 'The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)', 'detailedDescription': 'The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A) and Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)\n* Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)\n* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board\n* Patients who are scheduled to have implantable cardiac monitoring\n\nExclusion Criteria:\n\n* Transient ischemic attack\n* Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)\n* Presence of complex aortic atheroma (≥4mm in plaque thickness or presence of mobile components)\n* Presence of ≥50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area\n* Unwillingness or inability to comply with the procedures described in this protocol\n* Life expectancy \\< 1 years for any non-cardiac or cardiac causes'}, 'identificationModule': {'nctId': 'NCT04285918', 'acronym': 'DefenseElderly', 'briefTitle': 'Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale', 'orgStudyIdInfo': {'id': '2019-1112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature)', 'interventionNames': ['Procedure: Percutaneous device closure']}, {'label': 'Cohort B', 'description': 'Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO'}], 'interventions': [{'name': 'Percutaneous device closure', 'type': 'PROCEDURE', 'description': 'If there is no relevant AF detected for 6 months during intermittent follow-up or ICM, device closure of PFO is recommended for high-risk PFOs but is decided ultimately at the discretion of the attending physician. If there is any relevant AF identified from ICM or other modalities during follow-up, adequate secondary prevention with anticoagulants should be carried out. All this process and decision making should be a part of routine clinical practice.', 'armGroupLabels': ['Cohort A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Kwan Song', 'role': 'CONTACT', 'email': 'jksong@amc.seoul.kr', 'phone': '+82 3 3010 3155'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae-Kwan Song', 'role': 'CONTACT', 'email': 'jksong@amc.seoul.kr', 'phone': '+82 2 3010 3155'}, {'name': 'Jong S Kim', 'role': 'CONTACT', 'email': 'jongskim@amc.seoul.kr', 'phone': '+82 2 3010 3442'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jae-Kwan Song', 'investigatorFullName': 'Jae-Kwan Song', 'investigatorAffiliation': 'Asan Medical Center'}}}}