Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 2:46 AM
Study NCT ID:
NCT06010550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-25', 'studyFirstSubmitDate': '2023-08-20', 'studyFirstSubmitQcDate': '2023-08-20', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with stroke', 'timeFrame': 'Between 24 hours and 14 days after the emergency department visit', 'description': 'Number of participants with ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dizzy', 'Vertigo', 'Stroke', 'Machine learning'], 'conditions': ['Dizziness', 'Vertigo']}, 'descriptionModule': {'briefSummary': 'This study aims to validate a machine learning model that stratifies the risk of stroke in patients who present to the emergency department with dizziness or vertigo.', 'detailedDescription': 'This is a cross-sectional, hospital-based study, with no randomization procedure. Over a 21-month period, approximately 600 subjects will be enrolled. The study will assess the risk of stroke in each patient using a machine-learning model. To detect ischemic or hemorrhagic stroke, each patient will undergo a non-contrast brain magnetic resonance imaging study. The predictive performance of the machine-learning model will be evaluated in terms of accuracy, precision, recall, F1 score, and area under the receiver operating characteristics curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who visit the emergency department.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to the emergency department with dizziness or vertigo\n* Aged ≥ 20\n* Dizziness or vertigo lasting for at least 1 hour and \\< 7 days\n* Persistent dizziness or vertigo at the time of the examination at the emergency department\n\nExclusion Criteria:\n\n* Having 5 or more prior episodes similar in quality, intensity, and duration to the current symptoms, with at least one episode more than a year prior and one within the past year\n* Having frank stroke-like symptoms or signs, such as hemiparesis, facial asymmetry, dysarthria, dysphasia, ataxia, gaze palsy\n* Consciousness disturbance, Glasgow coma scale \\< 13\n* Severe dementia\n* Recent stroke within 3 months\n* Dizziness or vertigo thought to be the result of head injury, hypotension, medication/drug intoxication, hypoglycemia, electrolyte imbalance, anemia, hepatic encephalopathy, hydrocephalus, etc\n* Concomitant head or neck trauma\n* Severe degenerative cervical spondylosis\n* Having contraindications to magnetic resonance imaging examination'}, 'identificationModule': {'nctId': 'NCT06010550', 'briefTitle': 'Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Chiayi Christian Hospital'}, 'officialTitle': 'Validating a Clinical Decision Support Tool for Stratifying Stroke Risk in Patients Presenting With Dizziness to the Emergency Department', 'orgStudyIdInfo': {'id': 'IRB2023009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dizziness/vertigo', 'description': 'Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo.', 'interventionNames': ['Radiation: Magnetic resonance imaging']}], 'interventions': [{'name': 'Magnetic resonance imaging', 'type': 'RADIATION', 'description': 'Brain magnetic resonance imaging', 'armGroupLabels': ['Dizziness/vertigo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sheng-Feng Sung, MD, PhD', 'role': 'CONTACT', 'email': 'sfsung@cych.org.tw', 'phone': '886-5-2765041', 'phoneExt': '7284'}], 'overallOfficials': [{'name': 'Sheng-Feng Sung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ditmanson Medical Foundation Chia-Yi Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiayi Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}