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
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
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Ghent, Belgium
- Ghent University Hospital
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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 |
|---|---|
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Experimental: Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
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Carotid endarterectomy (CEA) will be performed on the patients
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
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Experimental: Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
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Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Carotid Stenting (CAS) will be performed on these patients.
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No Intervention: matched control group
Matched control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pre-operative neuropsychological state
Time Frame: pre-operative
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Pen and paper tests will be performed.
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pre-operative
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Post-operative neuropsychological state (3 weeks)
Time Frame: after 3 weeks
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Pen and paper tests will be performed.
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after 3 weeks
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Post-operative neuropsychological state (6 months)
Time Frame: after 6 months
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Pen and paper tests will be performed.
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after 6 months
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Post-operative neuropsychological state (1 year)
Time Frame: after 1 year
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Pen and paper tests will be performed.
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after 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Levels of biomarkers pre-operatively
Time Frame: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
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Levels of biomarkers (protein S100B) will also be examined pre-operatively.
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pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
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Determination of cardiovascular risks pre-operatively
Time Frame: pre-operatively
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questionnaires
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pre-operatively
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Determination of cardiovascular risks after 3 weeks
Time Frame: after 3 weeks
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questionnaires
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after 3 weeks
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Determination of cardiovascular risks after 6 months
Time Frame: after 6 months
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questionnaires
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after 6 months
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Determination of cardiovascular risks after 1 year
Time Frame: after 1 year
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questionnaires
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after 1 year
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Clinical neurological examination after 3 weeks
Time Frame: after 3 weeks
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after 3 weeks
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Clinical neurological examination after 6 months
Time Frame: after 6 months
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after 6 months
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Clinical neurological examination after 1 year
Time Frame: after 1 year
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after 1 year
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Peri-operative embolization
Time Frame: Peri-operative
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A transcranial doppler ultrasonography will be performed.
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Peri-operative
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Validation results
Time Frame: pre- and post-operative after 48 hours and 3 weeks
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MRI-scan will be used.
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pre- and post-operative after 48 hours and 3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
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