Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04759859
• Other study ID #: 1997246
• Status: Withdrawn
• Start date: January 22, 2013
• Est. completion date: January 2020

Study information

• Verified date: January 2014
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Locations

Country	Name	City	State
United States	Charleston Area Medical Center Vascular Center of Excellence	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short Form-36		7 days before surgery, 1-7 days after surgery and 6 months follow-up
Other	Beck Depression Inventory II		7 days before surgery, 1-7 days after surgery and 6 months after surgery
Other	State-Trait Anxiety Inventory		7 days before surgery, 1-7 days after surgery and 6 months after surgery
Other	An 11-point Numeric Pain Intensity Scale		7 days before surgery, 1-7 days after surgery and 6 months after surgery
Primary	A battery of eight neuropsychological tests		7 days before surgery, 1-7 days after surgery and 6 months after surgery
Secondary	Diffusion Weighted Magnetic Resonance Imaging		7 days before surgery, 1-7 days after surgery