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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University Ghent
Sponsor:
Collaborator:
University Hospital, Ghent
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01337128
First received: April 15, 2011
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Carotid Stenosis
Procedure: Carotid endarterectomy (CEA)
Procedure: Carotid stenting (CAS)
Procedure: Neurocognitive functions
Procedure: Levels of biomarkers
Procedure: Detection of peri-operative embolization
Procedure: Validation results

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Pre-operative neuropsychological state [ Time Frame: pre-operative ] [ Designated as safety issue: No ]
    Pen and paper tests will be performed.

  • Post-operative neuropsychological state (3 weeks) [ Time Frame: after 3 weeks ] [ Designated as safety issue: No ]
    Pen and paper tests will be performed.

  • Post-operative neuropsychological state (6 months) [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    Pen and paper tests will be performed.

  • Post-operative neuropsychological state (1 year) [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    Pen and paper tests will be performed.


Secondary Outcome Measures:
  • Levels of biomarkers pre-operatively [ Time Frame: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours ] [ Designated as safety issue: No ]
    Levels of biomarkers (protein S100B) will also be examined pre-operatively.

  • Determination of cardiovascular risks pre-operatively [ Time Frame: pre-operatively ] [ Designated as safety issue: No ]
    questionnaires

  • Determination of cardiovascular risks after 3 weeks [ Time Frame: after 3 weeks ] [ Designated as safety issue: No ]
    questionnaires

  • Determination of cardiovascular risks after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    questionnaires

  • Determination of cardiovascular risks after 1 year [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
    questionnaires

  • Clinical neurological examination after 3 weeks [ Time Frame: after 3 weeks ] [ Designated as safety issue: No ]
  • Clinical neurological examination after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
  • Clinical neurological examination after 1 year [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • Peri-operative embolization [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
    A transcranial doppler ultrasonography will be performed.

  • Validation results [ Time Frame: pre- and post-operative after 48 hours and 3 weeks ] [ Designated as safety issue: No ]
    MRI-scan will be used.


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Procedure: Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA) will be performed on the patients
Procedure: Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Procedure: Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Procedure: Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Procedure: Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Experimental: Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Procedure: Carotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these patients.
Procedure: Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Procedure: Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Procedure: Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Procedure: Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
No Intervention: matched control group
Matched control group.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337128

Contacts
Contact: Maarten Plessers Maarten.Plessers@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium
Contact: Frank Vermassen, Ph.D. , M.D.       Frank.Vermassen@ugent.be   
Principal Investigator: Frank Vermassen, Ph.D. , M.D.         
Sponsors and Collaborators
University Ghent
University Hospital, Ghent
Investigators
Principal Investigator: Frank Vermassen, Ph.D. , M.D. Ghent University Hospital
Principal Investigator: Guy Vingerhoets, Ph.D. , Professor University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01337128     History of Changes
Other Study ID Numbers: 2010/819
Study First Received: April 15, 2011
Last Updated: July 19, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014