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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Procedure: Carotid endarterectomy (CEA)
* Procedure: Carotid stenting (CAS)
* Procedure: Neurocognitive functions
* Procedure: Levels of biomarkers
* Procedure: Detection of peri-operative embolization
* Procedure: Validation results


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative neuropsychological state | Pen and paper tests will be performed. | pre-operative | 
| Post-operative neuropsychological state (3 weeks) | Pen and paper tests will be performed. | after 3 weeks | 
| Post-operative neuropsychological state (6 months) | Pen and paper tests will be performed. | after 6 months | 
| Post-operative neuropsychological state (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 | 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 | questionnaires | pre-operatively | 
| Determination of cardiovascular risks after 3 weeks | questionnaires | after 3 weeks | 
| Determination of cardiovascular risks after 6 months | questionnaires | after 6 months | 
| Determination of cardiovascular risks after 1 year | questionnaires | after 1 year | 
| 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 | A transcranial doppler ultrasonography will be performed. | Peri-operative | 
| Validation results | MRI-scan will be used. | pre- and post-operative after 48 hours and 3 weeks |