Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00919165

Enrollment

Registered

2009-06-12

Start date

2007-12-31

Completion date

2017-04-20

Last updated

2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function in Carotid Stenting

Keywords

carotid stenting, cognitive function, pre and post stent, severe carotid artery stenosis

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results