Clinical trial NCT01337128: Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Official title: Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2011-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Pre-operative neuropsychological state
timeFrame: pre-operative
measure: Post-operative neuropsychological state (3 weeks)
timeFrame: after 3 weeks
measure: Post-operative neuropsychological state (6 months)
timeFrame: after 6 months
measure: Post-operative neuropsychological state (1 year)
timeFrame: after 1 year
Secondary outcomes:
measure: Levels of biomarkers pre-operatively
timeFrame: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours
measure: Determination of cardiovascular risks pre-operatively
timeFrame: pre-operatively
measure: Determination of cardiovascular risks after 3 weeks
timeFrame: after 3 weeks
measure: Determination of cardiovascular risks after 6 months
timeFrame: after 6 months
measure: Determination of cardiovascular risks after 1 year
timeFrame: after 1 year
measure: Clinical neurological examination after 3 weeks
timeFrame: after 3 weeks
measure: Clinical neurological examination after 6 months
timeFrame: after 6 months
measure: Clinical neurological examination after 1 year
timeFrame: after 1 year
measure: Peri-operative embolization
timeFrame: Peri-operative
measure: Validation results
timeFrame: pre- and post-operative after 48 hours and 3 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Frank Vermassen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Guy Vingerhoets, Ph.D., Professor
role: PRINCIPAL_INVESTIGATOR
References: