Clinical trial NCT04759859: Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy
Official title: Relationship Between Neuropsychological Functioning and Cerebral Perfusion in Patients Undergoing Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carotid Artery Stenosis
Keywords: Carotid Endarterectomy
Neurocognitive Functioning
Cerebral Perfusion
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 patients undergoing elective carotid endarterectomy and 30 patients undergoing other peripheral vascular surgical procedures

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A battery of eight neuropsychological tests
timeFrame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery
Secondary outcomes:
measure: Diffusion Weighted Magnetic Resonance Imaging
timeFrame: 7 days before surgery, 1-7 days after surgery
Other outcomes:
measure: Short Form-36
timeFrame: 7 days before surgery, 1-7 days after surgery and 6 months follow-up
measure: Beck Depression Inventory II
timeFrame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery
measure: State-Trait Anxiety Inventory
timeFrame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery
measure: An 11-point Numeric Pain Intensity Scale
timeFrame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center Vascular Center of Excellence
state: West Virginia
Study officials:
affiliation: Charleston Area Medical Center Vascular Center of Excellence
name: Ali AbuRahma, MD
role: PRINCIPAL_INVESTIGATOR
References: