Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

Withdrawn

• Conditions: Carotid Artery Stenosis

• Registration Number: NCT04759859
• Lead Sponsor: CAMC Health System

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.

Study Timeline

• Study Start: 2013-01-22
• Study First Submitted: 2013-11-27
• Status Verified: 2014-01
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

1. History of Substance Use:

   History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.

2. 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

3. 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.

4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A battery of eight neuropsychological tests	7 days before surgery, 1-7 days after surgery and 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Diffusion Weighted Magnetic Resonance Imaging	7 days before surgery, 1-7 days after surgery

Trial Locations

Locations (1)

Charleston Area Medical Center Vascular Center of Excellence; 🇺🇸 Charleston, West Virginia, United States