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Clinical Trials/NCT04759859
NCT04759859
Withdrawn
N/A

Relationship Between Neuropsychological Functioning and Cerebral Perfusion in Patients Undergoing Carotid Endarterectomy

CAMC Health System1 site in 1 countryJanuary 22, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Carotid Artery Stenosis
Sponsor
CAMC Health System
Locations
1
Primary Endpoint
A battery of eight neuropsychological tests
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2013
End Date
January 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CAMC Health System
Responsible Party
Principal Investigator
Principal Investigator

Ali AbuRahma

Professor of Surgery

CAMC Health System

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing elective carotid endarterectomy or other peripheral vascular surgical procedures.
  • Ages 40-90

Exclusion Criteria

  • History of Substance Use:
  • History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.
  • Conditions that affect brain MRI/contraindications for MRI:
  • 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
  • Conditions that affect neuropsychological assessment:
  • 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.
  • General Contraindications:
  • Diagnosis with or history of any medical condition that, based on reasonable clinical judgment, would clinically contraindicate the patient undergoing any of the study procedures.

Outcomes

Primary Outcomes

A battery of eight neuropsychological tests

Time Frame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery

Secondary Outcomes

  • Diffusion Weighted Magnetic Resonance Imaging(7 days before surgery, 1-7 days after surgery)

Study Sites (1)

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