Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions
This study is currently recruiting participants.
Verified October 2012 by Stanford University
Sponsor:
Stanford University
Collaborator:
The Methodist Hospital, Houston
Information provided by (Responsible Party):
Wei Zhou, Stanford University
ClinicalTrials.gov Identifier:
NCT01718600
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
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Purpose
Microembolization is commonly associated with carotid artery stenting (CAS), but our understanding of subclinical microembolization is superficial. Through collaborative effects of multidisciplinary team-experts, novel approaches, and longitudinal evaluations, we hope to better understand the clinical significance and long-term cognitive effects of microemboli. This proposal may change our current clinical practice by providing a better outcome measure for carotid interventions and improving outcomes of CAS procedures through risk factor stratification. Our central hypothesis is that development of subclinical microemboli is associated with decline in cognitive function following CAS and that the risk of development of microemboli themselves is associated with patient- and procedure-related factors. We hope that this prospective study will help to clarify these important issues in the era of rapidly evolving percutaneous interventions.
| Condition | Intervention |
|---|---|
|
Carotid Artery Stenosis |
Behavioral: Neuropsychological testing |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Incidence of microemboli in correlation with changes in neurocognitive assessment performance [ Time Frame: 1 year following CAS procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Risk factor stratification for incidence of microemboli [ Time Frame: 1 year following CAS procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Neuroimaging Correlates
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. 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 proposal, we hope to determine the risk factors and cognitive effect of microembolization following carotid revascularization procedures.
|
Behavioral: Neuropsychological testing |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patient is male or female >40 yrs of age.
- Patient has occlusive extracranial carotid stenosis (≥70%)
- Patient is scheduled to undergo an endovascular intervention of a lesion in the extracranial carotid artery
- Patient agrees to voluntarily participate 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 magnetic resonance 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.
- Patient is unable to understand or sign the informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718600
Contacts
| Contact: Wei Zhou, MD | 650-493-5000 ext 67339 | weizhou@stanford.edu |
Locations
| United States, California | |
| Palo Alto Veterans Affairs | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Elizabeth Hitchner, MA 650-493-5000 ext 68632 hitchner@stanford.edu | |
| Principal Investigator: Wei Zhou, MD | |
Sponsors and Collaborators
Stanford University
The Methodist Hospital, Houston
More Information
Additional Information:
Publications:
| Responsible Party: | Wei Zhou, Professor of Surgery, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01718600 History of Changes |
| Other Study ID Numbers: | R01NS070308 |
| Study First Received: | October 29, 2012 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Stanford University:
|
carotid artery stenting neuropsychological testing microembolization MRI |
Additional relevant MeSH terms:
|
Carotid Stenosis Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013