Neuroimaging Correlates of Memory Decline Following Carotid Interventions

NCT02006095 | Completed DMC

• 1 other identifier: R21NS081416-01
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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

Keywords

carotid artery stenting; carotid endarterectomy; magnetic resonance imaging (MRI); neuropsychological testing; microemboli

Outcome Measures

Primary Outcomes (1)

• Brain MRI scans

  White matter abnormality and perfusion in correlation with microembolization and cognitive change

  6 months following the procedure

Study Arms (1)

Neuroimaging Correlates

Other: Magnetic resonance imaging; Behavioral: Neuropsychological testing

Interventions

Magnetic resonance imaging OTHER

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

Neuroimaging Correlates

Neuropsychological testing BEHAVIORAL

Neuroimaging Correlates

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing carotid intervention

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Palo Alto Veterans Affairs

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Magnetic Resonance Spectroscopy; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Wei Zhou, MD

  Palo Alto Veterans Affairs/Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: December 9, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (1)