Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 12:36 PM
Study NCT ID:
NCT07018167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Door-to-Needle Time on Stroke Outcomes at Gonesse Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], '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'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (in minutes) from hospital arrival to thrombolysis (Door-to-Needle Time).', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Ischemic Attack, Transient', 'Cerebral Infarction', 'Thrombolytic Therapy', 'Treatment Outcome']}, 'descriptionModule': {'briefSummary': "This study looks at how quickly stroke patients receive treatment after arriving at Gonesse Hospital and whether this affects their recovery. Researchers will measure the time between a patient's arrival and the start of clot-busting treatment (called Door-to-Needle Time), as well as the time from symptom onset to hospital arrival (Home-Time). The goal is to see if treatment delays impact recovery, and to find ways to improve stroke care in the hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients (aged 18 and over) admitted to the Gonesse Hospital for acute ischemic stroke. All participants must have received intravenous thrombolysis (r-tPA) initiated at the hospital during the 3-month study period. Only patients with complete clinical and time-tracking data enabling the calculation of Door-to-Needle Time will be included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Confirmed diagnosis of acute ischemic stroke on imaging\n* Initial acute stroke care provided at Gonesse Hospital during the study period (3 months)\n* Intravenous thrombolysis (r-tPA) initiated at the hospital\n* Availability of clinical and timing data to calculate Door-to-Needle Time (DNT)\n\nExclusion Criteria:\n\n* Patients with hemorrhagic stroke or subarachnoid hemorrhage (SAH)\n* Thrombolysis initiated before hospital arrival\n* Missing, incomplete, or unusable timing data for DNT calculation'}, 'identificationModule': {'nctId': 'NCT07018167', 'briefTitle': 'Impact of Door-to-Needle Time on Stroke Outcomes at Gonesse Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Gonesse'}, 'officialTitle': 'Impact of Door-to-Needle Time on Stroke Outcomes at Gonesse Hospital', 'orgStudyIdInfo': {'id': '0107_NEUROLOGIE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gonesse', 'state': 'France', 'country': 'France', 'facility': 'France', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Gonesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}