Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

July 12, 2023 updated by: Spectrum Health Hospitals

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

To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with severe carotid artery stenosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 45 days
45 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Steven Pastyrnak, PhD, Spectrum Health Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 20, 2017

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimated)

June 12, 2009

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-286

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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