Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05572320
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet Function and Neurological Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 386}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assesment of the health state at 6 months and 1 year after surgery', 'timeFrame': '6 months and 1 year', 'description': 'The health state will be evaluated by EuroQol 5-dimensions 3 level test at 6 months and 1 year'}], 'primaryOutcomes': [{'measure': 'Platelet function and neurological events', 'timeFrame': 'immediately before the surgery', 'description': "The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy"}, {'measure': 'TRAP, ADP and ASPI thresholds to predict neurological events', 'timeFrame': 'immediately before the surgery', 'description': 'It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events'}], 'secondaryOutcomes': [{'measure': 'Occurence of thromboembolic neurological events', 'timeFrame': "within 1 month of patients' enrolled or before the hospital discharge"}, {'measure': 'Occurrence of any complications', 'timeFrame': "within 1 month of patients' enrolled or before the hospital discharge", 'description': 'Occurrence of surgical and medical complications'}, {'measure': '6 months and 1 year mortality', 'timeFrame': '6 months and 1 year', 'description': 'Mortality at 6 months and 1 years after carotid surgery'}, {'measure': '6 months and 1 year neurological events', 'timeFrame': '6 months and 1 year', 'description': 'Occurrence of neurological events after 6 months and 1 year after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carotid thromboendarterectomy', 'Thromboembolic Stroke', 'Platelet function', 'Aggregometry', 'Vascular surgery', 'mortality', 'neurological events'], 'conditions': ['Stroke, Acute', 'Carotid Artery Diseases']}, 'referencesModule': {'references': [{'pmid': '32856558', 'type': 'BACKGROUND', 'citation': 'Ball STE, Taylor R, McCollum CN. Resistance to Antiplatelet Therapy Is Associated With Symptoms of Cerebral Ischemia in Carotid Artery Disease. Vasc Endovascular Surg. 2020 Nov;54(8):712-717. doi: 10.1177/1538574420947235. Epub 2020 Aug 28.'}, {'pmid': '19287328', 'type': 'BACKGROUND', 'citation': 'Reavey-Cantwell JF, Fox WC, Reichwage BD, Fautheree GL, Velat GJ, Whiting JH, Chi YY, Hoh BL. Factors associated with aspirin resistance in patients premedicated with aspirin and clopidogrel for endovascular neurosurgery. Neurosurgery. 2009 May;64(5):890-5; discussion 895-6. doi: 10.1227/01.NEU.0000341904.39691.2F.'}, {'pmid': '21557809', 'type': 'BACKGROUND', 'citation': 'Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.'}]}, 'descriptionModule': {'briefSummary': 'Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA).\n\nThe present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.', 'detailedDescription': 'Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing carotid thromboendoarterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Carotid Artery Diseases undergoing carotid thrombendarterectomy\n* Signed consent\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* New oral anticoagulant\n* Oral Vitamin k inhibitors\n* Platelet count \\<80000 per microliter\n* Ongoing ischemic stroke'}, 'identificationModule': {'nctId': 'NCT05572320', 'acronym': 'MULTINEUR', 'briefTitle': 'Platelet Function and Neurological Events', 'organization': {'class': 'OTHER', 'fullName': 'Scientific Institute San Raffaele'}, 'officialTitle': 'Platelet Function and Neurological Events Following Carotid Thromboendarterectomy', 'orgStudyIdInfo': {'id': 'CE:83/INT/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Platelet Aggregometry Testing', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Multiple Electrode Aggregometry (Multiplate) device'], 'description': '1.6 ml of blood collected in hirudin-coated tubes before the surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio Monaco, MD', 'role': 'CONTACT', 'email': 'monaco.fabrizio@hsr.it', 'phone': '022643', 'phoneExt': '7176'}], 'facility': 'Scientific Institute San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Fabrizio Monaco, MD', 'role': 'CONTACT', 'email': 'monaco.fabrizio@hsr.it', 'phone': '+39223467176'}, {'name': 'Fabrizio Monaco', 'role': 'CONTACT', 'email': 'monaco.fabrizio@hsr.it', 'phone': '+39223467176'}], 'overallOfficials': [{'name': 'Fabrizio Monaco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Raffaele Scientific Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scientific Institute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiothoracic and Vascular Anesthesia', 'investigatorFullName': 'Fabrizio Monaco', 'investigatorAffiliation': 'Scientific Institute San Raffaele'}}}}