Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carotid Stenosis
- Sponsor
- University Ghent
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pre-operative neuropsychological state
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Pre-operative neuropsychological state
Time Frame: pre-operative
Pen and paper tests will be performed.
Post-operative neuropsychological state (3 weeks)
Time Frame: after 3 weeks
Pen and paper tests will be performed.
Post-operative neuropsychological state (6 months)
Time Frame: after 6 months
Pen and paper tests will be performed.
Post-operative neuropsychological state (1 year)
Time Frame: after 1 year
Pen and paper tests will be performed.
Secondary Outcomes
- 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)
- Determination of cardiovascular risks pre-operatively(pre-operatively)
- Determination of cardiovascular risks after 3 weeks(after 3 weeks)
- Determination of cardiovascular risks after 6 months(after 6 months)
- Determination of cardiovascular risks after 1 year(after 1 year)
- Clinical neurological examination after 3 weeks(after 3 weeks)
- Peri-operative embolization(Peri-operative)
- Validation results(pre- and post-operative after 48 hours and 3 weeks)
- Clinical neurological examination after 1 year(after 1 year)