A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting

August 18, 2014 updated by: Panos Kougias, Baylor College of Medicine
This study compares cognitive function after carotid endarterectomy and stenting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid duplex

Exclusion Criteria:

  • Contraindication for carotid endarterectomy or stenting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carotid stenting
Carotid artery stenting for treatment of carotid artery stenosis
Procedure: Carotid endarterectomy vs. carotid stenting
Active Comparator: Carotid endarterectomy
Carotid artery endarterectomy for treatment of carotid artery stenosis
Procedure: Carotid endarterectomy vs. carotid stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in RAVLT score
Time Frame: Six weeks
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning
Time Frame: Six weeks and six months
Six weeks and six months
Cognitive tests of attention
Time Frame: Six weeks
Comparison in cognitive tests for attention between carotid endarterectomy and stenting
Six weeks
Cognitive tests for memory
Time Frame: Six weeks
Comparison in cognitive tests for memory between carotid endarterectomy and stenting
Six weeks
Cognitive tests for processing speed
Time Frame: Six weeks
Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting
Six weeks
Cognitive tests of mood
Time Frame: Six weeks
Comparison in cognitive tests for mood between carotid endarterectomy and stenting
Six weeks
Tests of motor function
Time Frame: Six weeks
Comparison in cognitive tests for motor function between carotid endarterectomy and stenting
Six weeks
Cognitive tests of visual-spatial skills
Time Frame: Six weeks
Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting
Six weeks
Cognitive tests of executive functioning
Time Frame: Six weeks
Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting
Six weeks
Cognitive tests of attention
Time Frame: Six months
Comparison in cognitive tests for attention between carotid endarterectomy and stenting
Six months
Cognitive tests of memory
Time Frame: Six weeks
Comparison in cognitive tests for memory between carotid endarterectomy and stenting
Six weeks
Cognitive tests of processing speed
Time Frame: Six months
Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting
Six months
Cognitive tests of mood
Time Frame: Six months
Comparison in cognitive tests for mood between carotid endarterectomy and stenting
Six months
Tests of motor function
Time Frame: Six months
Comparison in cognitive tests for motor function between carotid endarterectomy and stenting
Six months
Cognitive tests of visual-spatial skills
Time Frame: Six months
Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting
Six months
Cognitive tests of executive functioning
Time Frame: Six months
Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting
Six months
Difference in new ischemic infarcts in Diffusion - weighted MRI
Time Frame: Six weeks
Difference in new ischemic infarcts in Diffusion - weighted MRI
Six weeks
Difference in new ischemic infarcts in Diffusion - weighted MRI
Time Frame: Six months
Difference in new ischemic infarcts in Diffusion - weighted MRI
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H - 22797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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