Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718600
Recruitment Status : Unknown
Verified April 2015 by Wei Zhou, Stanford University.
Recruitment status was:  Recruiting
First Posted : October 31, 2012
Last Update Posted : April 6, 2015
University of Wisconsin, Madison
Washington University School of Medicine
Information provided by (Responsible Party):
Wei Zhou, Stanford University

October 29, 2012
October 31, 2012
April 6, 2015
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 ]
Same as current
Complete list of historical versions of study NCT01718600 on Archive Site
Risk factor stratification for incidence of microemboli [ Time Frame: 1 year following CAS procedure ]
Same as current
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Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
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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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients undergoing carotid intervention
Carotid Artery Stenosis
Behavioral: Neuropsychological testing
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 Identifier (NCT Number) in Medline.
Unknown status
Same as current
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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01NS070308( U.S. NIH Grant/Contract )
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Wei Zhou, Stanford University
Stanford University
  • University of Wisconsin, Madison
  • Washington University School of Medicine
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Stanford University
April 2015