Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Stanford University
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Wei Zhou, Stanford University
ClinicalTrials.gov Identifier:
NCT01718600
First received: October 29, 2012
Last updated: December 4, 2013
Last verified: December 2013

October 29, 2012
December 4, 2013
June 2011
June 2016   (final data collection date for primary outcome measure)
Incidence of microemboli in correlation with changes in neurocognitive assessment performance [ Time Frame: 1 year following CAS procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01718600 on ClinicalTrials.gov Archive Site
Risk factor stratification for incidence of microemboli [ Time Frame: 1 year following CAS procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
Not Provided

Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and long-term cognitive effects of microemboli. This proposal may change our current clinical practice by providing a better outcome measure for carotid interventions and improving outcomes of CAS procedures through risk factor stratification. Our central hypothesis is that development of subclinical microemboli is associated with decline in cognitive function following CAS and that the risk of development of microemboli themselves is associated with patient- and procedure-related factors. We hope that this prospective study will help to clarify these important issues in the era of rapidly evolving percutaneous interventions.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Carotid Artery Stenosis
Behavioral: Neuropsychological testing
No Intervention: Neuroimaging Correlates
Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this proposal, we hope to determine the risk factors and cognitive effect of microembolization following carotid revascularization procedures.
Intervention: Behavioral: Neuropsychological testing
Zhou W, Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective neurocognitive evaluation of patients undergoing carotid interventions. J Vasc Surg. 2012 Dec;56(6):1571-8. doi: 10.1016/j.jvs.2012.05.092. Epub 2012 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is male or female >40 yrs of age.
  • Patient has occlusive extracranial carotid stenosis (≥70%)
  • Patient is scheduled to undergo an endovascular intervention of a lesion in the extracranial carotid artery
  • Patient agrees to voluntarily participate and signs an informed consent.
  • Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
  • Patient has sufficient visual and auditory acuity for cognitive testing.

Exclusion Criteria:

  • Patient is unable to safely and comfortably undergo magnetic resonance imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
  • Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
  • Patient has prominent suicidal or homicidal ideation.
  • Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
  • Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
  • Patient has prior closed head injury with ≥24 hours of amnesia.
  • Patient is unable to understand or sign the informed consent.
Both
40 Years and older
Yes
Contact: Wei Zhou, MD 650-493-5000 ext 67339 weizhou@stanford.edu
United States
 
NCT01718600
R01NS070308
Yes
Wei Zhou, Stanford University
Stanford University
University of Wisconsin, Madison
Not Provided
Stanford University
December 2013

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