Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Carotid Artery Stenosis

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center Vascular Center of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

70 patients undergoing elective carotid endarterectomy and 30 patients undergoing other peripheral vascular surgical procedures

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Carotid Endarterectomy (CEA); 70 participants undergoing CEA
Other Peripheral Vascular Surgery; 30 participants undergoing other peripheral vascular surgical procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A battery of eight neuropsychological tests	7 days before surgery, 1-7 days after surgery and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Diffusion Weighted Magnetic Resonance Imaging	7 days before surgery, 1-7 days after surgery

Other Outcome Measures

Outcome Measure	Time Frame
Short Form-36	7 days before surgery, 1-7 days after surgery and 6 months follow-up
Beck Depression Inventory II	7 days before surgery, 1-7 days after surgery and 6 months after surgery
State-Trait Anxiety Inventory	7 days before surgery, 1-7 days after surgery and 6 months after surgery
An 11-point Numeric Pain Intensity Scale	7 days before surgery, 1-7 days after surgery and 6 months after surgery

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Ali AbuRahma, MD, Charleston Area Medical Center Vascular Center of Excellence

Study record dates

Study Major Dates

• Study Start (Anticipated): January 22, 2013
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Carotid Endarterectomy; Cerebral Perfusion; Neurocognitive Functioning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: 1997246