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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02006095
Other study ID # R21NS081416-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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