Neuroimaging Correlates of Memory Decline Following Carotid Interventions

NCT ID: NCT02006095

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-04-30

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.

Conditions

Carotid Artery Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neuroimaging Correlates

Magnetic resonance imaging

Intervention Type: OTHER

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

Neuropsychological testing

Intervention Type: BEHAVIORAL

Interventions

Magnetic resonance imaging

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

Intervention Type: OTHER

Neuropsychological testing

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Veterans Affairs/Stanford University

Locations

Palo Alto Veterans Affairs

Palo Alto, California, United States

Countries

United States

Other Identifiers

R21NS081416-01

Identifier Type: NIH

Identifier Source: org_study_id

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