Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-07 @ 12:32 AM
Study NCT ID:
NCT03166969
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2016-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring', 'timeFrame': 'Day 21', 'description': 'Atrial fibrillation \\>= 30 secondes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cryptogenic Transient Ischemic Attack and Minor Stroke']}, 'referencesModule': {'references': [{'pmid': '27495831', 'type': 'RESULT', 'citation': 'Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.014. Epub 2016 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.\n\nThis study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cryptogenic TIA/Minor stroke\n* Age \\> 18 years\n* Medical care in Neuro Vascular Unit of CH Versailles\n* Holter 21 days performed\n\nExclusion Criteria:\n\n1. ACFA history\n2. ECG or telemetry who showed ACFA before the Holter initializing\n3. Carotid Stenosis / symptomatic vertebral\n4. Arterial dissection\n5. Prothrombotic state demonstrated by laboratory tests\n6. Infective endocarditis'}, 'identificationModule': {'nctId': 'NCT03166969', 'acronym': 'HOLTER-21J', 'briefTitle': 'Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Versailles Hospital'}, 'orgStudyIdInfo': {'id': 'P14/08_HOLTER 21J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients taken care in neurovascular unit', 'interventionNames': ['Procedure: Holter 21 days']}], 'interventions': [{'name': 'Holter 21 days', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients taken care in neurovascular unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Centre Hospitalier de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versailles Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator coordinator', 'investigatorFullName': 'Pr Fernando PICO', 'investigatorAffiliation': 'Versailles Hospital'}}}}