Skip to main content
OpenTrials
Completed

NCT Number: NCT01337128

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid endarterectomy (CEA)

Procedure

Carotid endarterectomy (CEA) will be performed on the patients

Carotid stenting (CAS)

Procedure

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

Neurocognitive functions

Procedure

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

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.

Detection of peri-operative embolization

Procedure

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

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.

Primary outcomes

  1. Pre-operative neuropsychological state

    Time frame: pre-operative

    Pen and paper tests will be performed.

  2. Post-operative neuropsychological state (3 weeks)

    Time frame: after 3 weeks

    Pen and paper tests will be performed.

  3. Post-operative neuropsychological state (6 months)

    Time frame: after 6 months

    Pen and paper tests will be performed.

  4. Post-operative neuropsychological state (1 year)

    Time frame: after 1 year

    Pen and paper tests will be performed.

Secondary outcomes

  1. 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.

  2. Determination of cardiovascular risks pre-operatively

    Time frame: pre-operatively

    questionnaires

  3. Determination of cardiovascular risks after 3 weeks

    Time frame: after 3 weeks

    questionnaires

  4. Determination of cardiovascular risks after 6 months

    Time frame: after 6 months

    questionnaires

  5. Determination of cardiovascular risks after 1 year

    Time frame: after 1 year

    questionnaires

  6. Clinical neurological examination after 3 weeks

    Time frame: after 3 weeks

  7. Clinical neurological examination after 6 months

    Time frame: after 6 months

  8. Clinical neurological examination after 1 year

    Time frame: after 1 year

  9. Peri-operative embolization

    Time frame: Peri-operative

    A transcranial doppler ultrasonography will be performed.

  10. Validation results

    Time frame: pre- and post-operative after 48 hours and 3 weeks

    MRI-scan will be used.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University Hospital, Ghent

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 18, 2011
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.