Neuroimaging Correlates of Memory Decline Following Carotid Interventions

Carotid Artery Stenosis Clinical Trial

Official title:

Neuroimaging Correlates of Memory Decline Following Carotid Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006095
• Other study ID #: R21NS081416-01
• Status: Completed
• Start date: November 2012
• Est. completion date: April 2018

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Other:
• Magnetic resonance imaging
arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used

Behavioral:
• Neuropsychological testing

Locations

Country	Name	City	State
United States	Palo Alto Veterans Affairs	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain MRI scans	White matter abnormality and perfusion in correlation with microembolization and cognitive change	6 months following the procedure