Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-01 @ 5:14 PM
Study NCT ID:
NCT03992157
Status:
TERMINATED
Last Update Posted:
2020-01-02
First Post:
2019-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'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'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Medical practices have evolved and are not conform with the study procedure. Actually, all patients receive an ambulatory ECG telemetry monitoring', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-30', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-06-18', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic impact of outpatient ECG telemetry', 'timeFrame': '6 months', 'description': 'Percentage of patients hospitalized for cerebral infarction and with a diagnosis of atrial fibrillation allowed by the use of ambulatory ECG telemetry.'}], 'secondaryOutcomes': [{'measure': 'Identification of prognostic factors to identify de novo atrial fibrillation', 'timeFrame': '6 months', 'description': 'Retrospective evaluation of prognostic criteria (clinical data, biomarkers, abdominal MRI) in patients with a diagnosis of AF'}, {'measure': 'Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation', 'timeFrame': '6 months', 'description': 'Percentage of patients on anticoagulation at the end of hospitalisation'}, {'measure': 'Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service', 'timeFrame': '3 months', 'description': 'Percentage of IC recurrence in the department and within 3 months of the IC diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'ECG', 'telemetry', 'atrial fibrillation'], 'conditions': ['Cerebral Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to show that an ambulatory ECG telemetry monitoring of some patients hospitalized for cerebral infarction increases the frequency of the diagnosis of atrial fibrillation, cause of their stroke, and reinforces the protection against recurrences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Diagnosis of transient ischemic or cerebral accident\n* Absence of etiological orientation after the initial assessment (including at least cerebral MRI, angiography of the supra aortic trunks by CT or MRI, echocardiography with search for patent foramen ovale, standard biology)\n* Affiliated to a social security system.\n* Having given no opposition to participation in research\n\nExclusion Criteria:\n\n* AF known or diagnosed during stay in USINV'}, 'identificationModule': {'nctId': 'NCT03992157', 'acronym': 'TELEMETRIE', 'briefTitle': 'Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction', 'orgStudyIdInfo': {'id': '2016-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'holter-ECG', 'description': 'Implementation of an ECG Holter during hospitalisation patient.', 'interventionNames': ['Device: ECG telemetry']}, {'type': 'NO_INTERVENTION', 'label': 'Crontrole', 'description': 'No implementation of an ECG Holter'}], 'interventions': [{'name': 'ECG telemetry', 'type': 'DEVICE', 'description': 'ECG telemetry (holter ECG) is a portable case - attached to the belt or around the neck - connected to 6 electrodes placed on the skin next to the heart. They are worn by patients during their stay in hospital', 'armGroupLabels': ['holter-ECG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Bertrand Lapergue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}