Overview

This trial is active, not recruiting.

Condition cognitive function in carotid stenting
Sponsor Spectrum Health Hospitals
Collaborator Abbott Vascular
Start date December 2007
End date May 2014
Trial size 25 participants
Trial identifier NCT00919165, 2007-286

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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

Primary Outcomes

Measure
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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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.

Additional Information

Official title Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting
Principal investigator Dennis Dunning, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Spectrum Health Hospitals.