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Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Spectrum Health Hospitals.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919165
First Posted: June 12, 2009
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott Vascular
Information provided by:
Spectrum Health Hospitals
  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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Dennis Dunning, West Michigan Heart
ClinicalTrials.gov Identifier: NCT00919165     History of Changes
Other Study ID Numbers: 2007-286
First Submitted: June 11, 2009
First Posted: June 12, 2009
Last Update Posted: June 5, 2013
Last Verified: June 2013

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