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Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott Vascular
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00919165
First received: June 11, 2009
Last updated: June 3, 2013
Last verified: June 2013

June 11, 2009
June 3, 2013
December 2007
May 2014   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919165 on ClinicalTrials.gov Archive Site
to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting [ Time Frame: 45 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with severe carotid artery stenosis

Cognitive Function in Carotid Stenting
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00919165
2007-286
No
Dr. Dennis Dunning, West Michigan Heart
Spectrum Health Hospitals
Abbott Vascular
Principal Investigator: Dennis Dunning, MD Spectrum Health Hospitals
Spectrum Health Hospitals
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP