Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT05134493
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2021-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], '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': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'carotid plaque'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-14', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-11-14', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MES COUNT', 'timeFrame': 'before surgery', 'description': 'number of MES'}, {'measure': 'MES COUNT', 'timeFrame': '24 hours after surgery', 'description': 'number of MES'}, {'measure': 'MES COUNT', 'timeFrame': 'after 30 days from the surgery', 'description': 'number of MES'}], 'secondaryOutcomes': [{'measure': 'RISK RATE', 'timeFrame': 'through study completion, an average of 60 days', 'description': "Estimate an association between MES count and plaque's histology"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carotid', 'carotid stenosis', 'plaque', 'stroke risk', 'transcranial doppler', 'TCD', 'histology'], 'conditions': ['Carotid Stenosis', 'Carotid Artery Diseases', 'Carotid Atherosclerosis', 'Carotid Artery Plaque', 'TCD', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '36243263', 'type': 'DERIVED', 'citation': 'Pizzarelli G, Gennai S, Leone N, Covic T, Moratto R, Silingardi R. Transcranial Doppler detects micro emboli in patients with asymptomatic carotid stenoses undergoing endarterectomy. J Vasc Surg. 2023 Mar;77(3):811-817.e2. doi: 10.1016/j.jvs.2022.10.003. Epub 2022 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'About 20% of strokes are caused by emboli deriving from a carotid plaque. In symptomatic patients with carotid stenosis grater than 70% the Carotid Endarterectomy (CEA) reduces stroke risk by about 75% and is generally accepted as being cost effective. However also in these cases there is a part of the population that, according to the morphological plaque characteristics, could better benefit from a conservative medical treatment.\n\nImproving the Best Medical Treatment, the situation seems to be even less clear in asymptomatic patients, where probably it would need to treat at least 32 patients in order to prevent one single ictus.\n\nDifferent parameters have been considered in order to determine, among the asymptomatic patients the ones that more than others could benefit from a surgical revascularisation instead of a medical treatment.\n\nBetween these parameters, the quality of the plaque (vulnerability) and the micro-embolic signals (MES) detection with the Transcranial Doppler (TCD) Holter seems to be the most relevant.\n\nAnother interesting aspect is trying to establish whether plaques can determine a different embolic risk in relation to the different histological findings.\n\nTherefore, it seems interesting and reasonable trying to establish a correlation between these two parameters in asymptomatic patients as in the symptomatic ones in order to make more and more appropriate a surgical plaque removal according to the specific risk of each patient in a set of tailored surgery.\n\nIt consists in a descriptive observational study, since it intends to describe the embolic signals detection (MES) counted in automatic way with the TCD Holter, in patients affected by carotid stenosis, before and after the surgical operation.\n\nIn particular it consists in a monocentric, longitudinal, prospective cohort study since it intends to analyse a group of patients (already candidates to CEA) that experiences a specific event (MES) before and after the surgical plaque removal, in a precise span of time.\n\nSince the treatment, removing the plaque, should remove the embolic focus too, a significant reduction of microembolic signals in post-operative time is expected.\n\nThis reduction has been esteemed around about the 70% among candidates to CEA. Patients taken on responsibility of the equipe will undergo an ultrasonographic investigation for the carotid stenosis, histological characterization of the plaque based on the Gray-Weale classification and TCD-Holter for MES.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We selected patients already got in touch with the hospital, already put in list for a carotid surgical revascularization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed\n* Age\\>18y.o.\n* Carotid stenosis \\>70% and/or vulnerable plaque\n\nExclusion Criteria:\n\n* Inability to give the informed consent\n* Age\\<18y.o.\n* Carotid stenosis \\< 70 %\n* Patients already treated with CEA in the same seat\n* Impossibility to find the insonation window\n* Patients not in best medical treatment therapy'}, 'identificationModule': {'nctId': 'NCT05134493', 'briefTitle': 'Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Modena'}, 'officialTitle': 'Embolic Signals Detection Study (Esds) in Candidates for Surgical Carotid Revascularisation: a Comparison With Plaque Histological Findings', 'orgStudyIdInfo': {'id': '176/2018/OSS/AOUMO - MESTCD'}}, 'contactsLocationsModule': {'locations': [{'zip': '41126', 'city': 'Modena', 'country': 'Italy', 'facility': 'OCB Baggiovara, AOU Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Roberto Moratto, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AOU Modena e Reggio Emilia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Ginevra Pizzarelli, Medico in Formazione Specialistica', 'investigatorFullName': 'Ginevra Pizzarelli', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Modena'}}}}