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Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
Not Recruiting
Trial ID: NCT01718600
Purpose
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.
Official Title
Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
Eligibility
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.
Intervention(s):
behavioral: Neuropsychological testing
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Wei Zhou, MD
650-493-5000 Ext. 67339