search
Back to results

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

Primary Purpose

Carotid Stenosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Carotid endarterectomy (CEA)
Carotid stenting (CAS)
Neurocognitive functions
Levels of biomarkers
Detection of peri-operative embolization
Validation results
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Stenosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Carotid endarterectomy (CEA)

Carotid Stenting (CAS)

matched control group

Arm Description

Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.

Patients with carotid stenosis who are randomly assigned to a carotid stenting.

Matched control group.

Outcomes

Primary Outcome Measures

Pre-operative neuropsychological state
Pen and paper tests will be performed.
Post-operative neuropsychological state (3 weeks)
Pen and paper tests will be performed.
Post-operative neuropsychological state (6 months)
Pen and paper tests will be performed.
Post-operative neuropsychological state (1 year)
Pen and paper tests will be performed.

Secondary Outcome Measures

Levels of biomarkers pre-operatively
Levels of biomarkers (protein S100B) will also be examined pre-operatively.
Determination of cardiovascular risks pre-operatively
questionnaires
Determination of cardiovascular risks after 3 weeks
questionnaires
Determination of cardiovascular risks after 6 months
questionnaires
Determination of cardiovascular risks after 1 year
questionnaires
Clinical neurological examination after 3 weeks
Clinical neurological examination after 6 months
Clinical neurological examination after 1 year
Peri-operative embolization
A transcranial doppler ultrasonography will be performed.
Validation results
MRI-scan will be used.

Full Information

First Posted
April 15, 2011
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
University Hospital, Ghent
search

1. Study Identification

Unique Protocol Identification Number
NCT01337128
Brief Title
Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Official Title
Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carotid endarterectomy (CEA)
Arm Type
Experimental
Arm Description
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Arm Title
Carotid Stenting (CAS)
Arm Type
Experimental
Arm Description
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Arm Title
matched control group
Arm Type
No Intervention
Arm Description
Matched control group.
Intervention Type
Procedure
Intervention Name(s)
Carotid endarterectomy (CEA)
Intervention Description
Carotid endarterectomy (CEA) will be performed on the patients
Intervention Type
Procedure
Intervention Name(s)
Carotid stenting (CAS)
Intervention Description
Carotid Stenting (CAS) will be performed on these patients.
Intervention Type
Procedure
Intervention Name(s)
Neurocognitive functions
Intervention Description
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Intervention Type
Procedure
Intervention Name(s)
Levels of biomarkers
Intervention Description
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Intervention Type
Procedure
Intervention Name(s)
Detection of peri-operative embolization
Intervention Description
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Intervention Type
Procedure
Intervention Name(s)
Validation results
Intervention Description
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Primary Outcome Measure Information:
Title
Pre-operative neuropsychological state
Description
Pen and paper tests will be performed.
Time Frame
pre-operative
Title
Post-operative neuropsychological state (3 weeks)
Description
Pen and paper tests will be performed.
Time Frame
after 3 weeks
Title
Post-operative neuropsychological state (6 months)
Description
Pen and paper tests will be performed.
Time Frame
after 6 months
Title
Post-operative neuropsychological state (1 year)
Description
Pen and paper tests will be performed.
Time Frame
after 1 year
Secondary Outcome Measure Information:
Title
Levels of biomarkers pre-operatively
Description
Levels of biomarkers (protein S100B) will also be examined pre-operatively.
Time Frame
pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
Title
Determination of cardiovascular risks pre-operatively
Description
questionnaires
Time Frame
pre-operatively
Title
Determination of cardiovascular risks after 3 weeks
Description
questionnaires
Time Frame
after 3 weeks
Title
Determination of cardiovascular risks after 6 months
Description
questionnaires
Time Frame
after 6 months
Title
Determination of cardiovascular risks after 1 year
Description
questionnaires
Time Frame
after 1 year
Title
Clinical neurological examination after 3 weeks
Time Frame
after 3 weeks
Title
Clinical neurological examination after 6 months
Time Frame
after 6 months
Title
Clinical neurological examination after 1 year
Time Frame
after 1 year
Title
Peri-operative embolization
Description
A transcranial doppler ultrasonography will be performed.
Time Frame
Peri-operative
Title
Validation results
Description
MRI-scan will be used.
Time Frame
pre- and post-operative after 48 hours and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Vermassen, Ph.D., M.D.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy Vingerhoets, Ph.D., Professor
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs