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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: University Ghent

Current Primary Outcome:

  • Pre-operative neuropsychological state [ Time Frame: pre-operative ]
    Pen and paper tests will be performed.
  • Post-operative neuropsychological state (3 weeks) [ Time Frame: after 3 weeks ]
    Pen and paper tests will be performed.
  • Post-operative neuropsychological state (6 months) [ Time Frame: after 6 months ]
    Pen and paper tests will be performed.
  • Post-operative neuropsychological state (1 year) [ Time Frame: after 1 year ]
    Pen and paper tests will be performed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Levels of biomarkers pre-operatively [ Time Frame: 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 [ Time Frame: pre-operatively ]
    questionnaires
  • Determination of cardiovascular risks after 3 weeks [ Time Frame: after 3 weeks ]
    questionnaires
  • Determination of cardiovascular risks after 6 months [ Time Frame: after 6 months ]
    questionnaires
  • Determination of cardiovascular risks after 1 year [ Time Frame: after 1 year ]
    questionnaires
  • Clinical neurological examination after 3 weeks [ Time Frame: after 3 weeks ]
  • Clinical neurological examination after 6 months [ Time Frame: after 6 months ]
  • Clinical neurological examination after 1 year [ Time Frame: after 1 year ]
  • Peri-operative embolization [ Time Frame: Peri-operative ]
    A transcranial doppler ultrasonography will be performed.
  • Validation results [ Time Frame: pre- and post-operative after 48 hours and 3 weeks ]
    MRI-scan will be used.


Original Secondary Outcome:

  • Levels of biomarkers pre-operatively [ Time Frame: pre-operatively ]
    Levels of biomarkers (protein S100B) will also be examined pre-operatively.
  • Levels of biomarkers after 3 weeks [ Time Frame: after 3 weeks ]
    Levels of biomarkers (protein S100B) will also be examined pre-operatively.
  • Levels of biomarkers after 6 months [ Time Frame: after 6 months ]
    Levels of biomarkers (protein S100B) will also be examined after 6 months.
  • Level of biomarkers after 1 year [ Time Frame: after 1 year ]
    Levels of biomarkers (protein S100B) will also be examined after 1 year.
  • Determination of cardiovascular risks pre-operatively [ Time Frame: pre-operatively ]
    questionnaires
  • Determination of cardiovascular risks after 3 weeks [ Time Frame: after 3 weeks ]
    questionnaires
  • Determination of cardiovascular risks after 6 months [ Time Frame: after 6 months ]
    questionnaires
  • Determination of cardiovascular risks after 1 year [ Time Frame: after 1 year ]
    questionnaires
  • Clinical neurological examination after 3 weeks [ Time Frame: after 3 weeks ]
  • Clinical neurological examination after 6 months [ Time Frame: after 6 months ]
  • Clinical neurological examination after 1 year [ Time Frame: after 1 year ]
  • Peri-operative embolization [ Time Frame: Peri-operative ]
    A transcranial doppler ultrasonography will be performed.


Information By: University Ghent

Dates:
Date Received: April 15, 2011
Date Started: April 2011
Date Completion: September 2015
Last Updated: December 4, 2014
Last Verified: December 2014