Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-03 @ 10:54 AM
Study NCT ID:
NCT06515951
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2023-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2024-07-20', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of STANDING algorithm for the diagnosis of types of vertigo.', 'timeFrame': 'Thirty days', 'description': 'Accuracy (proportion of true positive and negative cases among the total number of cases examined) together with sensitivity, specificity, negative and positive predictive values, negative and positive likelihood ratios of STANDING algorithm performed by emergency physicians to distinguish central and peripheral vertigo.'}], 'secondaryOutcomes': [{'measure': 'Change in the use of neuroimaging', 'timeFrame': 'Thirty days', 'description': 'Evaluation if the use of STANDING algorithm can reduce the number neuroimaging (a composite of CT of the head and brain MRI) exams performed in patients with suspected central vertigo according to the STANDING algorithm.'}, {'measure': 'Safety of hospital discharge', 'timeFrame': 'Thirty days', 'description': 'Evaluation if the use of STANDING algorithm allows a safe discharge of patients with diagnosis of benign vertigo. At 1 month follow-up we evaluate the composite of: number of readmissions for stroke, need for cerebral revasculation procedures, for neurosurgery or all cause death or death for stroke) in patients without suspected central vertigo according to the STANDING algorithm.'}, {'measure': 'Accuracy for diagnosis of stroke', 'timeFrame': 'Thirty days', 'description': 'Accuracy (proportion of true positive and negative cases of stroke among the total number of cases examined)'}, {'measure': 'Change in the use of specialist consultant', 'timeFrame': 'thirty days', 'description': 'Evaluation if the use of STANDING algorithm can reduce the number of specialist medical consultations (composite of neurological and ENT consultations) performed in patients with suspected central vertigo according to the STANDING algorithm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central vertigo', 'Peripheral vertigo', 'Ischemic stroke'], 'conditions': ['Vertigo']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fneur.2017.00590/full', 'label': 'Validation STANDING study, monocentric'}, {'url': 'https://www.actaitalica.it/issues/2014/6-2014/08-Vanni.pdf', 'label': 'Derivation STANDING study, monocentric'}]}, 'descriptionModule': {'briefSummary': 'Differential diagnosis of vertigo is complex especially in emergency department, nevertheless it is crucial. The aim of this study is to assess the accuracy of STANDING algorithm for discriminate central from peripheral type of vertigo, identifying more easily the presence of ischemic stroke.', 'detailedDescription': 'Vertigo represents a common medical problem which afflicts about 20-30% of the population and it is a frequent cause of abstention from work and disability. In most cases it is provoked by a benign disease of inner ear, however it can be the main symptom of a more dangerous illness like ischemic or hemorragic stroke, cerebral neoplasm or demyelinating disease. Indeed, vertigo is the prevailing clinical problem in patients with misdiagnosed ischemic stroke, leading to an increase of mortality in the acute phase of disease. In the current state, two diagnostic algorithm have been proposed for the evaluation of acute vertigo, named with the acronyms HINTS and STANDING. The former is characterized by high sensibility and specificity when utilized by a specialist physician, but it is cumbersome to used in emergency department. Conversely, the latter has been validated exactly in this setting and comprises the evaluation of benign paroxysmal positional vertigo and of upright position. The aim of this study is to estimate the accuracy of STANDING algorithm in differentiating peripheral vertigo from central from, in particular ischemic stroke, and its potential usefulness in decreasing the use of neuroimaging and specialist consultant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Every adult patient presenting in emergency department with vertigo, dizziness or balance disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 18 years of age.\n* patients affected by vertigo, dizziness or balance disorder.\n\nExclusion Criteria:\n\n* age under 18.\n* patients unable to cooperate (with severe dementia or incapable to provide consensus).\n* patients affected by disease of cervical spine or any trauma of this part of body that contraindicate the manipulation of neck.\n* impractical follow-up.\n* dying patient (less three estimated months to live).\n* patients with neurologic deficit identified during triage examination (Cincinnati Prehospital stroke scale, CPSS\\>0) of suffering from another disease that can be the cause of dizziness/balance disorder (e.g. anemia, arrhythmia, hypoglycemia, alcoholic intoxication).\n* patients without symptoms at the time of examination.\n* patients who deny the participation in the study.'}, 'identificationModule': {'nctId': 'NCT06515951', 'acronym': 'STANDING-M', 'briefTitle': 'Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Diagnostic Accuracy of the STANDING Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: a Multicenter Study.', 'orgStudyIdInfo': {'id': '11085'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STANDING group', 'description': 'Consecutive adult patients who access the emergency room due to vertigo / imbalance will be considered eligible for the study. in this group patients will be evaluated by STANDING protocol', 'interventionNames': ['Diagnostic Test: STANDING algorithm']}, {'label': 'Control group', 'description': 'Consecutive adult patients who access the emergency room due to vertigo / imbalance will be considered eligible for the study. in this group patients will be evaluated by standard of care'}], 'interventions': [{'name': 'STANDING algorithm', 'type': 'DIAGNOSTIC_TEST', 'description': 'The STANDING algorithm is composed by four steps. The first phase consists in evaluating the presence of spontaneous nystagmus at rest for at least five minutes with and without Frenzel goggles in order to assess if a acute vestibular syndrome is present. If there is not a spontaneous nystagmus, then positional maneuvers (Pagnini-Mc Cure and Dix-Hallpike) have to be performed. Otherwise if spontaneous nystagmus is observed, its feature are fundamental to diagnose a central vertigo. If nystagmus characteristics suggest a peripheral form, the head impulse test is performed by instructing the patient to keep eyes on a fixed target and then turned the head quickly. An abnormal response is typical of vestibular neuritis. In any cases after the described maneuvers, the patient must be evaluated when standing up and walking: if this turn out to be impossibile, the test is indicative of central nervous system disease.', 'armGroupLabels': ['STANDING group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50053', 'city': 'Empoli', 'state': 'Firenze', 'country': 'Italy', 'facility': "Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica", 'geoPoint': {'lat': 43.71795, 'lon': 10.94758}}, {'zip': '55049', 'city': 'Viareggio', 'state': 'Lucca', 'country': 'Italy', 'facility': "Ospedale Versilia, Medicina d'Urgenza", 'geoPoint': {'lat': 43.86693, 'lon': 10.2502}}, {'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': "Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '59100', 'city': 'Prato', 'country': 'Italy', 'facility': "Nuovo Ospedale di Prato, Medicina d'Urgenza", 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}], 'overallOfficials': [{'name': 'Simone Magazzini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Direttore Dipartimento Emergenza Urgenza e Area Critica AUTC'}, {'name': 'Maurizio Bartolucci, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Direttore Dipartimento Diagnostica per immagini AUTC'}, {'name': 'Paola Bartalucci, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Medicina d'Urgenza Empoli AUTC"}, {'name': 'Claudia Casula, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Medicina d'Urgenza Empoli AUTC"}, {'name': 'Simone Vanni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Direttore SOC Medicina d'Urgenza EMPOLI; Direttore Area della Formazione Dipartimento Emergenza Urgenza e Area Critica AUTC"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peiman Nazerian', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale San Giuseppe di Empoli', 'class': 'OTHER'}, {'name': 'Ospedale Santo Stefano', 'class': 'OTHER'}, {'name': 'Azienda USL Toscana Nord Ovest', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Peiman Nazerian', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}