Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.

Not Applicable

Completed

• Conditions: Carotid Stenosis
• Interventions: Procedure: Carotid endarterectomy (CEA); Procedure: Carotid stenting (CAS); Procedure: Neurocognitive functions; Procedure: Levels of biomarkers; Procedure: Detection of peri-operative embolization; Procedure: Validation results

• Registration Number: NCT01337128
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Primary Completion: 2015-04
• Study Completion: 2015-09
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy (CEA)	Carotid endarterectomy (CEA)	Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Carotid endarterectomy (CEA)	Levels of biomarkers	Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Carotid endarterectomy (CEA)	Validation results	Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Carotid endarterectomy (CEA)	Detection of peri-operative embolization	Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Carotid Stenting (CAS)	Neurocognitive functions	Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Carotid endarterectomy (CEA)	Neurocognitive functions	Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Carotid Stenting (CAS)	Carotid stenting (CAS)	Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Carotid Stenting (CAS)	Levels of biomarkers	Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Carotid Stenting (CAS)	Detection of peri-operative embolization	Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Carotid Stenting (CAS)	Validation results	Patients with carotid stenosis who are randomly assigned to a carotid stenting.

Primary Outcome Measures

Name	Time	Method
Post-operative neuropsychological state (6 months)	after 6 months	Pen and paper tests will be performed.
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 (1 year)	after 1 year	Pen and paper tests will be performed.

Secondary Outcome Measures

Name	Time	Method
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.
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
Determination of cardiovascular risks after 1 year	after 1 year	questionnaires
Clinical neurological examination after 3 weeks	after 3 weeks
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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium