Carotid Stenosis
Conditions
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.
Interventions
PROCEDURECarotid endarterectomy (CEA)
Carotid endarterectomy (CEA) will be performed on the patients
PROCEDURECarotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these patients.
PROCEDURENeurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
PROCEDURELevels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
PROCEDUREDetection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
PROCEDUREValidation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Sponsors
University Hospital, Ghent
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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. |
| Clinical neurological examination after 1 year | after 1 year | — |
| 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 |
Countries
Belgium
Outcome results
None listed