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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Carotid endarterectomy (CEA) will be performed on the patients
Carotid Stenting (CAS) will be performed on these 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.
Ghent University Hospital
Ghent, Belgium
Pre-operative neuropsychological state
Pen and paper tests will be performed.
Time frame: pre-operative
Post-operative neuropsychological state (3 weeks)
Pen and paper tests will be performed.
Time frame: after 3 weeks
Post-operative neuropsychological state (6 months)
Pen and paper tests will be performed.
Time frame: after 6 months
Post-operative neuropsychological state (1 year)
Pen and paper tests will be performed.
Time frame: after 1 year
Levels of biomarkers pre-operatively
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
Determination of cardiovascular risks pre-operatively
questionnaires
Time frame: pre-operatively
Determination of cardiovascular risks after 3 weeks
questionnaires
Time frame: after 3 weeks
Determination of cardiovascular risks after 6 months
questionnaires
Time frame: after 6 months
Determination of cardiovascular risks after 1 year
questionnaires
Time frame: after 1 year
Clinical neurological examination after 3 weeks
Time frame: after 3 weeks
Clinical neurological examination after 6 months
Time frame: after 6 months
Clinical neurological examination after 1 year
Time frame: after 1 year
Peri-operative embolization
A transcranial doppler ultrasonography will be performed.
Time frame: Peri-operative
Validation results
MRI-scan will be used.
Time frame: pre- and post-operative after 48 hours and 3 weeks
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