Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03570060
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stepwise Screening for Silent Atrial Fibrillation After Stroke
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of atrial fibrillation during continuous monitoring in a Stroke unit within six months of stroke.', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '37429637', 'type': 'DERIVED', 'citation': 'Didier R, Garnier L, Duloquin G, Meloux A, Sagnard A, Graber M, Dogon G, Benali K, Pommier T, Laurent G, Vergely C, Bejot Y, Guenancia C. Distribution of atrial cardiomyopathy markers and association with atrial fibrillation detected after ischaemic stroke in the SAFAS study. Stroke Vasc Neurol. 2024 Apr 30;9(2):165-173. doi: 10.1136/svn-2023-002447.'}, {'pmid': '35911547', 'type': 'DERIVED', 'citation': 'Garnier L, Duloquin G, Meloux A, Benali K, Sagnard A, Graber M, Dogon G, Didier R, Pommier T, Vergely C, Bejot Y, Guenancia C. Multimodal Approach for the Prediction of Atrial Fibrillation Detected After Stroke: SAFAS Study. Front Cardiovasc Med. 2022 Jul 13;9:949213. doi: 10.3389/fcvm.2022.949213. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (AF) in the acute phase after stroke. In this prospective work, the investigators will rely on the Dijon Stroke Registry, which collects extensive clinical data for each patient hospitalized for a stroke. As part of this registry, patients are seen 6 months after stroke to assess their clinical status. This clinical follow-up will allow us to judge the evolution of the AF diagnosed during the acute episode at a distance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who had an ischemic stroke defined according to WHO criteria and hospitalized in the Stroke Unit at the Dijon University Hospital.\n* Patient 18 years of age and older\n* Patient who has given oral consent\n\nExclusion Criteria:\n\n* Person not affiliated to a national health insurance scheme\n* Protected adult\n* Pregnant or breastfeeding woman\n* Patient refusing to participate in the study\n* Transfer planned after the stay in the Stroke Unit to a department outside the Dijon University Hospital, not allowing for the long term screening with an external ECG monitor\n* History of atrial fibrillation or atrial flutter\n* Patient wearing a pacemaker or defibrillator with an atrial lead'}, 'identificationModule': {'nctId': 'NCT03570060', 'acronym': 'SAFAS', 'briefTitle': 'Stepwise Screening for Silent Atrial Fibrillation After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Stepwise Screening for Silent Atrial Fibrillation After Stroke', 'orgStudyIdInfo': {'id': 'GUENANCIA 2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': '2 ml of blood for testing for serum biomarkers (IL-6, GDF-15, soluble ST-2 soluble, osteoprotegerin, galectin 3)'}, {'name': 'Long term ECG monitor', 'type': 'PROCEDURE', 'description': 'Fitting and removal of a long term ECG monitor (SpiderFlash, LivaNova)'}, {'name': 'Monitoring ECG', 'type': 'PROCEDURE', 'description': 'Recording of automatic ECG monitor results (CSM Philips IntelliVue MP50 system)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}