Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

NCT04759859 | Withdrawn

• 1 other identifier: 1997246
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenosis

Keywords

Carotid Endarterectomy; Neurocognitive Functioning; Cerebral Perfusion

Outcome Measures

Primary Outcomes (1)

• A battery of eight neuropsychological tests

  7 days before surgery, 1-7 days after surgery and 6 months after surgery

Secondary Outcomes (1)

• Diffusion Weighted Magnetic Resonance Imaging

  7 days before surgery, 1-7 days after surgery

Other Outcomes (4)

• 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

Study Arms (2)

Carotid Endarterectomy (CEA)

70 participants undergoing CEA

Other Peripheral Vascular Surgery

30 participants undergoing other peripheral vascular surgical procedures

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• History of Substance Use:
• History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.
• 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
• 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.
• 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.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center Vascular Center of Excellence

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ali AbuRahma, MD

  Charleston Area Medical Center Vascular Center of Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: February 18, 2021
• Study Start: January 22, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 18, 2021

Record last verified: 2014-01

Locations

US (1)