Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

Completed

• Conditions: Cognitive Function in Carotid Stenting

• Registration Number: NCT00919165
• Lead Sponsor: Spectrum Health Hospitals

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2017-03
• Study Completion: 2017-04-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis	45 days

Secondary Outcome Measures

Name	Time	Method
to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting	45 days

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States