Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 7:18 AM
Study NCT ID:
NCT03985059
Status:
TERMINATED
Last Update Posted:
2021-03-30
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'no need to include more patients for analysis. 40 patients initially (36 actual)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2019-06-11', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler', 'timeFrame': '2 minutes', 'description': 'Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler (defined by a variation of more than 10%) on the symptomatic side evaluated in transcranial Doppler when changing from the lying position (0°) to the 90° position (measured 2 minutes after verticalization).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Verticalization', 'Doppler', 'Intracranial hemodynamic', 'Cerebral artery velocity'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid recanalization.\n\nThe impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.\n\nThe main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited during their hospitalization in the USINV for the management of ischemic stroke.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ischemic stroke (AIC) or transient ischemic attack (AIT) of the carotid artery\n* Duration of symptoms less than 48 hours\n* Absence of homolateral or downstream intracranial stenosis or occlusion M1\n* Lifting authorized by the referent clinician.\n* Rankin's score before AIC/AIT ≤ 2\n\n • For cases:\n* Carotid stenosis of more than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion\n\n • For controls:\n* Absence of carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or occlusion\n\nExclusion Criteria:\n\n\\- Disrupted vigilance\n\nSecondary exclusion criteria:\n\n* Absence of a homolateral temporal acoustic window at the lesion\n* Impossibility to verticalize the patient"}, 'identificationModule': {'nctId': 'NCT03985059', 'acronym': 'STAND', 'briefTitle': 'Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND : iSchemic sTroke evAluated at Bed Side With ultrasouND)', 'orgStudyIdInfo': {'id': 'MMI_2018_12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with ischemic stroke or transient ischemic attack who have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.', 'interventionNames': ['Other: Transcranial Doppler']}, {'label': 'Controls', 'description': 'Patients with ischemic stroke or transient ischemic attack who do not have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.', 'interventionNames': ['Other: Transcranial Doppler']}], 'interventions': [{'name': 'Transcranial Doppler', 'type': 'OTHER', 'description': "Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet.\n\nAfter 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the helmet.", 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}