NCT Number: NCT01718600
Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
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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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Palo Alto Veterans Affairs, Palo Alto, California, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Incidence of microemboli in correlation with changes in neurocognitive assessment performance
Time frame: 1 year following CAS procedure
Secondary outcomes
-
Risk factor stratification for incidence of microemboli
Time frame: 1 year following CAS procedure
Sponsors and collaborators
Lead sponsor
Stanford University
Other
Collaborators
- University of Wisconsin, Madison
- Washington University School of Medicine
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Oct 31, 2012
- Registry last updated
- Aug 29, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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