- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006095
Neuroimaging Correlates of Memory Decline Following Carotid Interventions
August 24, 2022 updated by: Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
207
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Palo Alto, California, United States, 94304
- Palo Alto Veterans Affairs
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing carotid intervention
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neuroimaging Correlates
|
arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain MRI scans
Time Frame: 6 months following the procedure
|
White matter abnormality and perfusion in correlation with microembolization and cognitive change
|
6 months following the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wei Zhou, MD, Palo Alto Veterans Affairs/Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2012
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
October 29, 2012
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 24, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21NS081416-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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