Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott Vascular
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00919165
First received: June 11, 2009
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis


Condition
Cognitive Function in Carotid Stenting

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2007
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
control and study group
severe carotid artery stenosis in asymptomatic patients defined as greater than 80% stenosis angiographically or greater than 400 cm/sec peak systolic velocity on carotid doppler evaluation

Detailed Description:

Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with severe carotid artery stenosis

Criteria

Inclusion Criteria:

  • 40-80 years of age
  • Right hand dominate
  • Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
  • Baseline doppler study with a peak systolic velocity of 400cm/sec
  • Patient is deemed candidate for carotid artery stenting
  • TIMI flow of 1,2 or 3
  • 80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS
  • Subjects are able to give informed consent
  • Subjects are willing/able to complete follow-up visits

Exclusion Criteria:

  • History of major stroke: within the past 6 months
  • History of Alzheimers disease or Dementia
  • Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
  • Planned intervention opposite carotid artery within 2 months
  • Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
  • Any individual identified with cognitive impairment which would affect their performance during cognitive testing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919165

Locations
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Abbott Vascular
Investigators
Principal Investigator: Dennis Dunning, MD Spectrum Health Hospitals
  More Information

No publications provided

Responsible Party: Dr. Dennis Dunning, West Michigan Heart
ClinicalTrials.gov Identifier: NCT00919165     History of Changes
Other Study ID Numbers: 2007-286
Study First Received: June 11, 2009
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:
carotid stenting
cognitive function
pre and post stent
severe carotid artery stenosis

ClinicalTrials.gov processed this record on April 22, 2014