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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337128
• Other study ID #: 2010/819
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: September 2015

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA) will be performed on the patients
• Carotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these patients.
• Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
• Levels of biomarkers
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
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
• Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-operative neuropsychological state	Pen and paper tests will be performed.	pre-operative
Primary	Post-operative neuropsychological state (3 weeks)	Pen and paper tests will be performed.	after 3 weeks
Primary	Post-operative neuropsychological state (6 months)	Pen and paper tests will be performed.	after 6 months
Primary	Post-operative neuropsychological state (1 year)	Pen and paper tests will be performed.	after 1 year
Secondary	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
Secondary	Determination of cardiovascular risks pre-operatively	questionnaires	pre-operatively
Secondary	Determination of cardiovascular risks after 3 weeks	questionnaires	after 3 weeks
Secondary	Determination of cardiovascular risks after 6 months	questionnaires	after 6 months
Secondary	Determination of cardiovascular risks after 1 year	questionnaires	after 1 year
Secondary	Clinical neurological examination after 3 weeks		after 3 weeks
Secondary	Clinical neurological examination after 6 months		after 6 months
Secondary	Clinical neurological examination after 1 year		after 1 year
Secondary	Peri-operative embolization	A transcranial doppler ultrasonography will be performed.	Peri-operative
Secondary	Validation results	MRI-scan will be used.	pre- and post-operative after 48 hours and 3 weeks