Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 11:43 PM
Study NCT ID:
NCT04771468
Status:
UNKNOWN
Last Update Posted:
2021-09-02
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output measurement', 'timeFrame': 'Up to 6 hours after clot removal', 'description': 'Changes of cardiac output of the enrolled patients before and after clot removal.'}, {'measure': 'Arterial elastance measurement', 'timeFrame': 'Up to 6 hours after clot removal', 'description': 'Changes of arterial elastance of the enrolled patients before and after clot removal.'}, {'measure': 'Arterial blood pressure measurement', 'timeFrame': 'Up to 6 hours after clot removal', 'description': 'Changes of arterial blood pressure of the enrolled patients before and after clot removal.'}, {'measure': 'Heart rate variability measurement', 'timeFrame': 'Up to 6 hours after clot removal', 'description': 'Changes of heart rate variability of the enrolled patients before and after clot removal.'}], 'secondaryOutcomes': [{'measure': 'Transthoracic echocardiography', 'timeFrame': 'at the admission', 'description': 'Ejection Fraction measurement'}, {'measure': 'Transthoracic Echocardiography', 'timeFrame': 'up to 3 weeks after clot removal', 'description': 'wave E assessment'}, {'measure': 'Transthoracic Echocardiography', 'timeFrame': 'up to 3 weeks after clot removal', 'description': 'wave A assessment'}, {'measure': 'Transthoracic Echocardiography', 'timeFrame': 'up to 3 weeks after clot removal', 'description': "wave e' assessment"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for acute ischemic stroke', 'eligibilityCriteria': 'Inclusion criteria\n\n1. Adult patients aged ≥ 18 years.\n2. Acute supratentorial or carotid stroke. Exclusion criteria\n\n1\\. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions:\n\n1. Intraoperative technical limitations limiting or impeding the arterial re-opening\n2. Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.'}, 'identificationModule': {'nctId': 'NCT04771468', 'briefTitle': '"Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Clinical and Research Center'}, 'officialTitle': '"Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".', 'orgStudyIdInfo': {'id': 'STROKE_EMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sovratentorial ischemic stroke', 'interventionNames': ['Device: MOSTCAREup Monitoring', 'Device: Ecocardiography']}], 'interventions': [{'name': 'MOSTCAREup Monitoring', 'type': 'DEVICE', 'description': 'The patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access).', 'armGroupLabels': ['Sovratentorial ischemic stroke']}, {'name': 'Ecocardiography', 'type': 'DEVICE', 'description': 'Echocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure.', 'armGroupLabels': ['Sovratentorial ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Messina, MD', 'role': 'CONTACT', 'email': 'antonio.messina@humanitas.it', 'phone': '+390282241'}, {'name': 'Antonio Messina, MD', 'role': 'CONTACT', 'email': 'mess81rc@gmail.com', 'phone': '+3902822414131'}], 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Clinical and Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}