Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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: Carotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these 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.
|
| No Intervention: matched control group Matched control group. |
Outcome Measures
Primary Outcome Measures
- Pre-operative neuropsychological state [pre-operative]
Pen and paper tests will be performed.
- Post-operative neuropsychological state (3 weeks) [after 3 weeks]
Pen and paper tests will be performed.
- Post-operative neuropsychological state (6 months) [after 6 months]
Pen and paper tests will be performed.
- Post-operative neuropsychological state (1 year) [after 1 year]
Pen and paper tests will be performed.
Secondary Outcome Measures
- Levels of biomarkers pre-operatively [pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours]
Levels of biomarkers (protein S100B) will also be examined pre-operatively.
- Determination of cardiovascular risks pre-operatively [pre-operatively]
questionnaires
- Determination of cardiovascular risks after 3 weeks [after 3 weeks]
questionnaires
- Determination of cardiovascular risks after 6 months [after 6 months]
questionnaires
- Determination of cardiovascular risks after 1 year [after 1 year]
questionnaires
- Clinical neurological examination after 3 weeks [after 3 weeks]
- Clinical neurological examination after 6 months [after 6 months]
- Clinical neurological examination after 1 year [after 1 year]
- Peri-operative embolization [Peri-operative]
A transcranial doppler ultrasonography will be performed.
- Validation results [pre- and post-operative after 48 hours and 3 weeks]
MRI-scan will be used.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ghent University Hospital | Ghent | Belgium |
Sponsors and Collaborators
- University Ghent
- University Hospital, Ghent
Investigators
- Principal Investigator: Frank Vermassen, Ph.D., M.D., University Hospital, Ghent
- Principal Investigator: Guy Vingerhoets, Ph.D., Professor, University Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010/819