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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid endarterectomy (CEA) | Experimental | Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy. |
|
| Carotid Stenting (CAS) | Experimental | Patients with carotid stenosis who are randomly assigned to a carotid stenting. |
|
| matched control group | No Intervention | Matched control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid endarterectomy (CEA) | Procedure | Carotid endarterectomy (CEA) will be performed on the patients |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Vermassen, Ph.D., M.D. | University Hospital, Ghent | Principal Investigator |
| Guy Vingerhoets, Ph.D., Professor | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | Belgium |
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| Carotid stenting (CAS) | Procedure | Carotid Stenting (CAS) will be performed on these patients. |
|
| Neurocognitive functions | Procedure | Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year. |
|
| Levels of biomarkers | Procedure | Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours. |
|
| Detection of peri-operative embolization | Procedure | A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization. |
|
| Validation results | Procedure | On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks. |
|
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 |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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