Neuroimaging Correlates of Memory Decline Following Carotid Interventions

Sponsor

Stanford University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02006095

Collaborator

(none)

100

Enrollment

Location

29.9

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. Characterizing risk factors for cognitive decline following carotid interventions and individualizing treatment strategy based on those risks can minimize procedure-associated cognitive dysfunction. 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 protocol, we hope to determine how cerebral blood flow and baseline white matter abnormality in the vulnerable region modify the frequency and cognitive effect of microembolization following carotid revascularization procedures.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis	Other: Magnetic resonance imaging Behavioral: Neuropsychological testing

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Nov 1, 2012

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Neuroimaging Correlates	Other: Magnetic resonance imaging arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used Behavioral: Neuropsychological testing

Arm

Intervention/Treatment

Neuroimaging Correlates

Other: Magnetic resonance imaging

arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used

Behavioral: Neuropsychological testing

Outcome Measures

Primary Outcome Measures

Brain MRI scans [6 months following the procedure]
White matter abnormality and perfusion in correlation with microembolization and cognitive change

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 a carotid revascularization procedure
Patient agrees to voluntarily participate in the study 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 MR 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.