Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.

November 18, 2021 updated by: University Ghent
In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will also be gathered. The mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between CEA and CAS regarding postoperative neuropsychological functions. The use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. It will meet several flaws of previous studies and will complete the ongoing randomized studies comparing CEA and CAS that are lacking neuropsychological data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Belgium
      • Ghent, Belgium
        • Ghent University Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with carotid stenosis.

Exclusion Criteria:

  • Significant medical conditions which affect neurocognitive functions (e.g. cancer, epilepsy)
  • Older than 80 years
  • A history of psychiatric or neurological illness
  • Severe alcohol of drug abuse
  • Coronary artery bypass graft (CABG) less than a year ago.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Procedure: Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA) will be performed on the patients
Procedure: Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Procedure: Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Procedure: Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Procedure: Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Experimental: Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Procedure: Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Procedure: Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Procedure: Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Procedure: Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Procedure: Carotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these patients.
No Intervention: matched control group
Matched control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-operative neuropsychological state
Time Frame: pre-operative
Pen and paper tests will be performed.
pre-operative
Post-operative neuropsychological state (3 weeks)
Time Frame: after 3 weeks
Pen and paper tests will be performed.
after 3 weeks
Post-operative neuropsychological state (6 months)
Time Frame: after 6 months
Pen and paper tests will be performed.
after 6 months
Post-operative neuropsychological state (1 year)
Time Frame: after 1 year
Pen and paper tests will be performed.
after 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of biomarkers pre-operatively
Time Frame: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
Levels of biomarkers (protein S100B) will also be examined pre-operatively.
pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
Determination of cardiovascular risks pre-operatively
Time Frame: pre-operatively
questionnaires
pre-operatively
Determination of cardiovascular risks after 3 weeks
Time Frame: after 3 weeks
questionnaires
after 3 weeks
Determination of cardiovascular risks after 6 months
Time Frame: after 6 months
questionnaires
after 6 months
Determination of cardiovascular risks after 1 year
Time Frame: after 1 year
questionnaires
after 1 year
Clinical neurological examination after 3 weeks
Time Frame: after 3 weeks
after 3 weeks
Clinical neurological examination after 6 months
Time Frame: after 6 months
after 6 months
Clinical neurological examination after 1 year
Time Frame: after 1 year
after 1 year
Peri-operative embolization
Time Frame: Peri-operative
A transcranial doppler ultrasonography will be performed.
Peri-operative
Validation results
Time Frame: pre- and post-operative after 48 hours and 3 weeks
MRI-scan will be used.
pre- and post-operative after 48 hours and 3 weeks

Collaborators and Investigators

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

Sponsor

University Ghent

Collaborators

University Hospital, Ghent

Investigators

  • Principal Investigator: Guy Vingerhoets, Ph.D., Professor, University Ghent
  • Principal Investigator: Frank Vermassen, Ph.D., M.D., University Hospital, Ghent

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 (Actual)

April 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/819

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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