Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-03 @ 4:32 PM
Study NCT ID:
NCT04759859
Status:
WITHDRAWN
Last Update Posted:
2021-02-18
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'logistical issues with coordinating the clinical and testing areas', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Short Form-36', 'timeFrame': '7 days before surgery, 1-7 days after surgery and 6 months follow-up'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': '7 days before surgery, 1-7 days after surgery and 6 months after surgery'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '7 days before surgery, 1-7 days after surgery and 6 months after surgery'}, {'measure': 'An 11-point Numeric Pain Intensity Scale', 'timeFrame': '7 days before surgery, 1-7 days after surgery and 6 months after surgery'}], 'primaryOutcomes': [{'measure': 'A battery of eight neuropsychological tests', 'timeFrame': '7 days before surgery, 1-7 days after surgery and 6 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Diffusion Weighted Magnetic Resonance Imaging', 'timeFrame': '7 days before surgery, 1-7 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carotid Endarterectomy', 'Neurocognitive Functioning', 'Cerebral Perfusion'], 'conditions': ['Carotid Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the relationship between neuropsychological functioning and brain perfusion in patients undergoing carotid endarterectomy and control patients undergoing other peripheral vascular procedures.', 'detailedDescription': "Carotid endarterectomy (CEA) is a vascular surgical procedure that is aimed at reducing accumulated cholesterol and fats in carotid arteries. While some research indicates that CEA is associated with improvements in neuropsychological functioning, other studies have identified deficits in neuropsychological functioning following CEA. The factors associated with these different outcomes are unclear. Identification of the factors that mediate post-CEA neuropsychological functioning outcomes may allow for the development of interventions that would improve such outcomes. Recent research has identified a relationship between post-CEA neuropsychological deficits, and cerebral blood flow in certain areas of the brain, with some indication that brain cell loss following CEA may be a key factor. The proposed study will explore changes in cerebral blood flow through the use of diffusion-weighted magnetic resonance images (DW-MRI) to investigate the relationship between neuropsychological functioning and brain perfusion in 70 CEA patients and to compare neuropsychological functioning of the CEA patients to a control group of 30 patients undergoing other peripheral vascular surgical procedures. Patients' neuropsychological functioning will be assessed pre, post and six months after the CEA or peripheral vascular surgery. Additionally DW-MRI will be assessed pre and post surgery for the patients undergoing CEA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '70 patients undergoing elective carotid endarterectomy and 30 patients undergoing other peripheral vascular surgical procedures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective carotid endarterectomy or other peripheral vascular surgical procedures.\n* Ages 40-90\n\nExclusion Criteria:\n\n1. History of Substance Use:\n\n History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.\n2. Conditions that affect brain MRI/contraindications for MRI:\n\n Diagnosis of HIV. History of any traumatic brain injury. History or current diagnosis with any form of brain tumor. Current normal pressure hydrocephalus. Patients with any implanted metallic medical device, or non-removable metallic material in their body\n3. Conditions that affect neuropsychological assessment:\n\n Diagnosis with Attention Deficit/Hyperactivity Disorder. Current major depressive episode. Current manic episode. Current psychotic episode. Diagnosis with any developmental disorder. Diagnosis with any form of dementia (MMSE\\<24). A score higher than 3 on the Modified Rankin Scale indicating a major stroke.\n4. General Contraindications:\n\nDiagnosis with or history of any medical condition that, based on reasonable clinical judgment, would clinically contraindicate the patient undergoing any of the study procedures.'}, 'identificationModule': {'nctId': 'NCT04759859', 'briefTitle': 'Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'CAMC Health System'}, 'officialTitle': 'Relationship Between Neuropsychological Functioning and Cerebral Perfusion in Patients Undergoing Carotid Endarterectomy', 'orgStudyIdInfo': {'id': '1997246'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carotid Endarterectomy (CEA)', 'description': '70 participants undergoing CEA'}, {'label': 'Other Peripheral Vascular Surgery', 'description': '30 participants undergoing other peripheral vascular surgical procedures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Charleston Area Medical Center Vascular Center of Excellence', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Ali AbuRahma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charleston Area Medical Center Vascular Center of Excellence'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CAMC Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Ali AbuRahma', 'investigatorAffiliation': 'CAMC Health System'}}}}