NCT00919165CompletedNot Applicable
Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Spectrum Health Hospitals
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis
Study Overview
Brief Summary
To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting(45 days)
Investigators
Study Sites (1)
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