Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-31 @ 9:31 AM
Study NCT ID:
NCT05534295
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strokecopilot: A Precision Medicine Tool in the Stroke Emergency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective analysis of thrombolysis data for the development of an algorithm to detect thrombolysis', 'timeFrame': 'Files analysed retrospectively from January 01, 2017 to December 31, 2021 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebrovascular accident (CVA)', 'Ischemic stroke', 'thrombolysis channels', 'intravenous thrombolysis', 'mechanical thrombectomy'], 'conditions': ['Cerebrovascular Accident (CVA)']}, 'descriptionModule': {'briefSummary': 'Ischemic stroke or cerebral infarction (CI) is an immediate emergency affecting approximately 100,000 - 150,000 patients each year in France and is managed in the neurovascular intensive care unit (NICU). Recanalization treatments can prevent disability, but patients must be carefully selected. Knowledge in this field is evolving rapidly, which tends to make management more complex and personalized. In addition, the permanence of thrombolysis channels involves neurologists of all expertise. Decision support tools are desirable to enable precision medicine in stroke. Strokecopilot is a web application developed by the principal investigator. Its algorithm contextualizes the patient in a set of evidence-based medicine references (recommendations and clinical trials) and gives the result of their cross-referencing to the user to indicate theoretical indications for intravenous thrombolysis and mechanical thrombectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (\\>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Adult patient (\\>18 years old) admitted to the thrombolysis unit of the University Hospital of Strasbourg from January 01, 2017 to December 31, 2021\n\nExclusion criteria:\n\n\\- Subjects who have expressed their opposition to the use of their data for scientific research purposes.'}, 'identificationModule': {'nctId': 'NCT05534295', 'acronym': 'Strokecopilot', 'briefTitle': 'Strokecopilot: A Precision Medicine Tool in the Stroke Emergency', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Strokecopilot: A Precision Medicine Tool in the Stroke Emergency', 'orgStudyIdInfo': {'id': '8589'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valérie WOLFF, MD, PhD', 'role': 'CONTACT', 'email': 'valerie.wolff@chru-strasbourg.fr', 'phone': '33 3 88 12 85 19'}, {'name': 'Valérie WOLFF, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stanislas DEMUTH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joris MULLER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service : Unité Neurovasculaire - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Valérie WOLFF, MD, PhD', 'role': 'CONTACT', 'email': 'valerie.wolff@chru-strasbourg.fr', 'phone': '33 3 88 12 85 19'}], 'overallOfficials': [{'name': 'Valérie WOLFF, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service : Unité Neurovasculaire - CHU de Strasbourg - France'}, {'name': 'Stanislas DEMUTH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service : Unité Neurovasculaire - CHU de Strasbourg - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}