Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-28 @ 12:22 PM
Study NCT ID:
NCT00861133
Status:
UNKNOWN
Last Update Posted:
2009-05-05
First Post:
2009-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryptogenic Stroke Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-04', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of atrial fibrillation at one year from Sleuth implantation.', 'timeFrame': 'One Year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiac monitor', 'loop recorder', 'stroke', 'ECG', 'Implantable Loop Recorder', 'cryptogenic', 'ILR'], 'conditions': ['Cryptogenic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.\n* Negative brain image for hemorrhagic stroke\n* In sinus rhythm at time of enrollment\n\nExclusion Criteria:\n\n* Know history of atrial fibrillation\n* Previous implanted cardiac device (ppM or ICD)\n* Serious illness making it unlikely to survive one year\n* Known secondary cause of stroke'}, 'identificationModule': {'nctId': 'NCT00861133', 'briefTitle': 'Cryptogenic Stroke Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transoma Medical'}, 'officialTitle': 'Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke', 'orgStudyIdInfo': {'id': 'CLP-008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sleuth AT Implantable ECG Monitoring System', 'type': 'DEVICE', 'description': 'The study device provides monitoring only. It cannot provide intervention or treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'M Broich', 'role': 'CONTACT', 'email': 'mbroich@transomamedical.com'}], 'overallOfficials': [{'name': 'Andrew Krahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transoma Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wim Stegink', 'oldOrganization': 'Tranoma Medical'}}}}