Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-29 @ 12:03 AM
Study NCT ID:
NCT06170034
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2023-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-emergency Management of Patients With Transient Ischemic Attack
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess time between arrival in the emergency department for suspected TIA patients and MRI.', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Time between arrival in the emergency department and MRI by departments.', 'timeFrame': 'Baseline'}, {'measure': 'Time between arrival in the emergency department and MRI by ABCD² score.', 'timeFrame': 'Baseline'}, {'measure': 'Percentage of patients with complete TIA management by departments.', 'timeFrame': 'Baseline'}, {'measure': 'Hospitalization times according to care units', 'timeFrame': 'Baseline'}, {'measure': 'Hospitalization times according to complete TIA management', 'timeFrame': 'Baseline'}, {'measure': 'Percentage of patients with secondary event, according to complete TIA management', 'timeFrame': 'Baseline'}, {'measure': 'Number of outpatients without complete TIA management one month after TIA.', 'timeFrame': 'At 1 month follow-up'}, {'measure': 'Patient satisfaction with a short questionnaire', 'timeFrame': 'At 1 month follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency', 'Cerebral RMI', 'Guidelines compliance'], 'conditions': ['Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': 'A transient ischemic attack (TIA) is a momentary neurological dysfunction due to a brief cessation of blood flow to a region of the brain, resulting in typical signs of stroke (hemiplegia, aphasia, dysarthria), but whose clinical symptoms typically last less than an hour, with no visible lesion on imaging. This diagnosis remains difficult and is essentially based on the clinical judgment of the physician.\n\nBecause a TIA can be a "pre-alarm" for stroke in 20-30% of cases, it needs to be treated appropriately and as early as possible in the emergency department. Stroke rates after untreated TIA are 5% within 48 hours, 10% within one month and 20% within one year. This risk is calculated using the ABCD² score which is based on the patient\'s risk factors and the clinical manifestations of TIA. Patients with a score ≥ 3 should be hospitalized as soon as possible for a complete medical evaluation. However, this score has not been scientifically validated, and several specialists agree that all TIAs should be evaluated immediately. Preventing stroke is a major public health issue because it is a serious, disabling and sometimes fatal disease. Given the seriousness of the progression from TIA to stroke, the French National Authority for Health has issued a series of management recommendations. However, in practice, these guidelines remain complicated to follow and patients management may vary and be more or less effective.\n\nTherefore, the aim of this study is to highlight the differences in how inpatients and outpatients are managed. Following these observations, solutions will be sought to make the care and management of these patients more efficient and more in line with recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of TIA in the emergency department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years old.\n* Consultation in the emergency department.\n* Suspected TIA diagnosed by emergency physician.\n* Duration of TIA symptoms \\<1 hour.\n\nExclusion Criteria:\n\n* Validation MRI performed prior to suspected TIA.\n* Patient hospitalized for a condition other than TIA, including stroke.\n* Patient referred to another hospital for further examination.\n* Pregnant women.\n* Patient unable to understand and answer a questionnaire.\n* Patient under legal protection.'}, 'identificationModule': {'nctId': 'NCT06170034', 'briefTitle': 'Post-emergency Management of Patients With Transient Ischemic Attack', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Henri Duffaut - Avignon'}, 'officialTitle': 'Post-emergency Management of Patients With Transient Ischemic Attack', 'orgStudyIdInfo': {'id': 'PEC AIT 84'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TIA patients', 'interventionNames': ['Behavioral: Satisfaction questionnaire', 'Other: Medical care questionnaire']}], 'interventions': [{'name': 'Satisfaction questionnaire', 'type': 'BEHAVIORAL', 'description': 'Satisfaction questionnaire to assess how TIA patients feels about their medical care.', 'armGroupLabels': ['TIA patients']}, {'name': 'Medical care questionnaire', 'type': 'OTHER', 'description': 'Recording appointments and results of examinations and consultations in TIA management', 'armGroupLabels': ['TIA patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avignon', 'country': 'France', 'facility': "Centre Hospitalier d'Avignon", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}], 'overallOfficials': [{'name': 'Yohan Fouilhe, Medical Intern', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Hospitalier d'Avignon, Service des urgences"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Henri Duffaut - Avignon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}