Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

Sponsor

Stanford University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01718600

Collaborator

University of Wisconsin, Madison (Other), Washington University School of Medicine (Other)

200

Enrollment

Locations

Duration (Months)

66.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis	Behavioral: Neuropsychological testing

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Neuropsychological testing

Arm

Intervention/Treatment

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.

Behavioral: Neuropsychological testing

Outcome Measures

Primary Outcome Measures

Incidence of microemboli in correlation with changes in neurocognitive assessment performance [1 year following CAS procedure]

Secondary Outcome Measures

Risk factor stratification for incidence of microemboli [1 year following CAS procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Veterans Affairs	Palo Alto	California	United States	94304
2	Washington University School of Medicine	St Louis	Missouri	United States	63110
3	University of Wisconsin, Madison	Madison	Wisconsin	United States