Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

NCT ID: NCT00919165

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2017-04-20

Brief Summary

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

Detailed Description

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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

Conditions

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Cognitive Function in Carotid Stenting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Pastyrnak, PhD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

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Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2007-286

Identifier Type: -

Identifier Source: org_study_id

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