Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT07198893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Prehospital Stroke Care Patterns on Clinical Outcomes in Acute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2025-09-20', 'studyFirstSubmitQcDate': '2025-09-27', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke symptom awareness', 'timeFrame': 'Baseline', 'description': 'Assessment of general knowledge and recognition of stroke symptoms and prehospital care pathways will be measured using the Stroke Knowledge Test (SKT), a validated questionnaire.\n\nThe SKT consists of 20 multiple-choice questions evaluating recognition of stroke symptoms and knowledge of emergency response. Scores range from 0 to 20, with higher scores indicating greater awareness and better knowledge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehospital Stroke Care', 'Patient Outcome:'], 'conditions': ['Prehospital Stroke Care']}, 'referencesModule': {'references': [{'pmid': '36444720', 'type': 'BACKGROUND', 'citation': 'Zachrison KS, Nielsen VM, de la Ossa NP, Madsen TE, Cash RE, Crowe RP, Odom EC, Jauch EC, Adeoye OM, Richards CT. Prehospital Stroke Care Part 1: Emergency Medical Services and the Stroke Systems of Care. Stroke. 2023 Apr;54(4):1138-1147. doi: 10.1161/STROKEAHA.122.039586. Epub 2022 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates how prehospital care factors, including stroke awareness, emergency response, transport, and referral processes, impact patient outcomes in acute stroke cases.', 'detailedDescription': "The research is a population-based observational cohort study conducted at Assiut University Hospital's Neuropsychiatry Department. It investigates patterns of prehospital stroke care with a focus on patient and caregiver awareness of stroke symptoms, the type of first medical contact, transport modes, referral pathways, and emergency medical service response. The study aims to understand how these prehospital factors influence stroke outcomes, including timely access to treatment, functional recovery, and mortality rates. Standardized tools, structured questionnaires, EMS records, and hospital medical data will be used to collect comprehensive information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are adult patients aged 18 years and above with an acute ischemic or hemorrhagic stroke diagnosis confirmed by neuroimaging. All patients must reside within the defined geographical area and have used emergency medical services or presented directly with stroke symptoms. Caregivers will also provide data regarding symptom recognition and decision-making. Patients with stroke mimics, incomplete records, or without consent will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥18 years of age\n\nConfirmed diagnosis of acute stroke (ischemic/hemorrhagic) verified by CT or MRI\n\nResidents of the study's defined geographical area\n\nPatients who experienced stroke and sought prehospital care pathways (EMS or direct hospital presentation)\n\nInformed consent from the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Patients with transient ischemic attack (TIA) or stroke mimics without confirmed acute stroke diagnosis\n\nMissing or incomplete data on prehospital care\n\nPatients unable or unwilling to provide consent without a representative available\n\nNon-residents or visitors outside the designated geographical area"}, 'identificationModule': {'nctId': 'NCT07198893', 'briefTitle': 'Impact of Prehospital Stroke Care Patterns on Clinical Outcomes in Acute Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Pattern and Impact of Prehospital Stroke Care on Patient Outcome: A Population-Based Study', 'orgStudyIdInfo': {'id': 'Prehospital Stroke Care'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adults who present with acute stroke', 'description': "The study population consists of adults who present with acute stroke and have sought or received prehospital care within the hospital's catchment area. Participants are adult patients aged 18 years and above with an acute ischemic or hemorrhagic stroke diagnosis confirmed by neuroimaging"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the Neuropsychiatry department', 'investigatorFullName': 'Refat Hamed Khalaf Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}