Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-02 @ 12:03 PM
Study NCT ID:
NCT07138768
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of MRI in the Early Diagnosis and Management of Acute Stroke and Its Impact on Turnaround Time in Emergency Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of magnetic resonance imaging for acute stroke', 'timeFrame': 'Immediately post-procedure (Up to 1 hour)', 'description': 'Sensitivity of magnetic resonance imaging for acute stroke will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Magnetic Resonance Imaging', 'Diagnosis', 'Management', 'Acute Stroke', 'Turnaround Time', 'Emergency Settings']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the role of stroke protocol in the early diagnosis and management of acute stroke and its effect on turnaround time (TAT) in emergency settings.', 'detailedDescription': 'Acute stroke is a common and often devastating disorder; however, acute treatments that reduce long-term disability are available if patients present within the time window for treatment.\n\nComputed tomography (CT) or magnetic resonance imaging (MRI) has been used in comprehensive stroke centers, although the role of advanced imaging in the improvement of stroke outcome remains controversial.\n\nMRI offers advantages for the assessment of acute stroke. Changes of acute ischaemic injury are detectable sooner with MRI than with CT, especially with diffusion-weighted imaging, and ischaemic stroke diagnosis with MRI has greater interobserver and intraobserver reliability than CT, even in readers with little experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective cohort study will be carried out on 136 patients presenting with acute stroke symptoms after approval from the institutional ethical committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with acute stroke who are admitted to the emergency department.\n\nExclusion Criteria:\n\n* Contraindications to magnetic resonance imaging (MRI) or computed tomography (CT).\n* Symptoms strongly suggestive of subarachnoid hemorrhage.\n* Initiation of antithrombotic or thrombolytic treatment before the completion of both scans.\n* Inability to complete both scans in time to allow thrombolytic treatment within three h of the onset of symptoms.\n* Uncontrollable hypertension.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT07138768', 'briefTitle': 'Role of MRI in the Early Diagnosis and Management of Acute Stroke and Its Impact on Turnaround Time in Emergency Settings', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Role of MRI in the Early Diagnosis and Management of Acute Stroke and Its Impact on Turnaround Time (TAT) in Emergency Settings', 'orgStudyIdInfo': {'id': '36264PR1258/6/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with acute stroke who are admitted to the emergency department.', 'interventionNames': ['Device: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'DEVICE', 'description': 'Magnetic Resonance Imaging will be performed to all patients', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hend M Mansour, MD', 'role': 'CONTACT', 'email': 'hend.mansour@med.tanta.edu.eg', 'phone': '00201221474344'}, {'name': 'Radwa Mohamed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hala Desoky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed H Mattar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emad H Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Hend M Mansour, MD', 'role': 'CONTACT', 'email': 'hend.mansour@med.tanta.edu.eg', 'phone': '00201221474344'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Emergency Medicine and Trauma, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Hend Mohammed Mansour', 'investigatorAffiliation': 'Tanta University'}}}}