Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting

Spectrum Health Hospitals1 site in 1 country19 target enrollmentDecember 2007

ConditionsCognitive Function in Carotid Stenting

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cognitive Function in Carotid Stenting
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
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

April 20, 2017

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Spectrum Health Hospitals

Responsible Party

Sponsor

Eligibility 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.

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