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

NCT01337128 | Completed

• 1 other identifier: 2010/819
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (10)

• 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

Study Arms (3)

Carotid endarterectomy (CEA)

EXPERIMENTAL

Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.

Procedure: Carotid endarterectomy (CEA); Procedure: Neurocognitive functions; Procedure: Levels of biomarkers; Procedure: Detection of peri-operative embolization; Procedure: Validation results

Carotid Stenting (CAS)

EXPERIMENTAL

Patients with carotid stenosis who are randomly assigned to a carotid stenting.

Procedure: Carotid stenting (CAS); Procedure: Neurocognitive functions; Procedure: Levels of biomarkers; Procedure: Detection of peri-operative embolization; Procedure: Validation results

matched control group

NO INTERVENTION

Matched control group.

Interventions

Carotid endarterectomy (CEA) PROCEDURE

Carotid endarterectomy (CEA) will be performed on the patients

Carotid endarterectomy (CEA)

Carotid stenting (CAS) PROCEDURE

Carotid Stenting (CAS) will be performed on these patients.

Carotid Stenting (CAS)

Neurocognitive functions PROCEDURE

Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.

Carotid Stenting (CAS); Carotid endarterectomy (CEA)

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.

Carotid Stenting (CAS); Carotid endarterectomy (CEA)

Detection of peri-operative embolization PROCEDURE

A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.

Carotid Stenting (CAS); Carotid endarterectomy (CEA)

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.

Carotid Stenting (CAS); Carotid endarterectomy (CEA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with carotid stenosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Frank Vermassen, Ph.D., M.D.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Guy Vingerhoets, Ph.D., Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

BE (1)