Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
Study NCT ID:
NCT04327492
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2020-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample. atherosclerotic plaque'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 272}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke', 'timeFrame': '30 days, long-term'}, {'measure': 'Clavien dindo>3', 'timeFrame': '30 days, long-term'}, {'measure': 'MACE', 'timeFrame': '30 days, long-term', 'description': 'AMI, stroke, Major adverse limb event, acute hear faillure hospitalization, all cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Stenosis', 'Carotid Endarterectomy']}, 'descriptionModule': {'briefSummary': 'Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.', 'detailedDescription': 'The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.\n\nEstablish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.\n\nClarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis.\n\nImagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients selected and submited to carotid endarterectomy under regional anesthesia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia\n\nExclusion Criteria:\n\n* general anesthesia\n* carotid stenting'}, 'identificationModule': {'nctId': 'NCT04327492', 'briefTitle': 'Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia', 'orgStudyIdInfo': {'id': '250-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carotid endarterectomy', 'description': 'This study is a non-interventional prospective cohort study. The population corresponds to patients submitted to CEA under regional anesthesia. Consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) will be prospectively recruited. The expected patient follow-up will be of 5 years.\n\nThe demographics will be recorded in a prospective, protected database. Blood samples will be collected in clot activator serum tubes at three timepoints: timepoint 1 - before surgery (until 15 days before surgery); timepoint 2 up to 48h postoperatively; timepoint', 'interventionNames': ['Diagnostic Test: Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP']}], 'interventions': [{'name': 'Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP', 'type': 'DIAGNOSTIC_TEST', 'description': 'peak wave velocity; gray weale plaque classification', 'armGroupLabels': ['Carotid endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'contacts': [{'name': 'Departamento FMUP', 'role': 'CONTACT', 'email': 'fmup@med.up.pt', 'phone': '(+351) 22 551 3600'}], 'facility': 'Faculdade de Medicina da Universidade do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Joao R Neves, MD, MSC; MPH', 'role': 'CONTACT', 'email': 'joaorochaneves@hotmail.com', 'phone': '+351910486230'}], 'overallOfficials': [{'name': 'Joao R Neves, MD, MSC, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSC; MPH, FEBVS', 'investigatorFullName': 'João Rocha Neves', 'investigatorAffiliation': 'Universidade do Porto'}}}}