Clinical trial NCT02006095: Neuroimaging Correlates of Memory Decline Following Carotid Interventions
Official title: Neuroimaging Correlates of Memory Decline Following Carotid Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Stenosis
Keywords: carotid artery stenting
carotid endarterectomy
magnetic resonance imaging (MRI)
neuropsychological testing
microemboli
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 207
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing carotid intervention

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.


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.

Primary outcomes:
measure: Brain MRI scans
timeFrame: 6 months following the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veterans Affairs
state: California
Study officials:
affiliation: Palo Alto Veterans Affairs/Stanford University
name: Wei Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: