Skip to content

Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04759859
Enrollment
0
Registered
2021-02-18
Start date
2013-01-22
Completion date
2020-01-31
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis

Keywords

Carotid Endarterectomy, Neurocognitive Functioning, Cerebral Perfusion

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.

Interventions

None listed

Sponsors

CAMC Health System
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
A battery of eight neuropsychological tests7 days before surgery, 1-7 days after surgery and 6 months after surgery

Secondary

MeasureTime frame
Diffusion Weighted Magnetic Resonance Imaging7 days before surgery, 1-7 days after surgery

Other

MeasureTime frame
Short Form-367 days before surgery, 1-7 days after surgery and 6 months follow-up
Beck Depression Inventory II7 days before surgery, 1-7 days after surgery and 6 months after surgery
State-Trait Anxiety Inventory7 days before surgery, 1-7 days after surgery and 6 months after surgery
An 11-point Numeric Pain Intensity Scale7 days before surgery, 1-7 days after surgery and 6 months after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026