Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

NCT01718600 | Completed DMC

• 1 other identifier: R01NS070308
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenting; neuropsychological testing; microembolization; MRI

Outcome Measures

Primary Outcomes (1)

• Incidence of microemboli in correlation with changes in neurocognitive assessment performance

  1 year following CAS procedure

Secondary Outcomes (1)

• Risk factor stratification for incidence of microemboli

  1 year following CAS procedure

Study Arms (1)

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

Interventions

Neuropsychological testing BEHAVIORAL

Neuroimaging Correlates

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing carotid intervention

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• University of Wisconsin, Madison: collaborator
• Washington University School of Medicine: collaborator

Study Sites (3)

Palo Alto Veterans Affairs

Palo Alto, California, 94304, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, United States

Location

Related Publications (1)

• Zhou W, Hitchner E, Gillis K, Sun L, Floyd R, Lane B, Rosen A. Prospective neurocognitive evaluation of patients undergoing carotid interventions. J Vasc Surg. 2012 Dec;56(6):1571-8. doi: 10.1016/j.jvs.2012.05.092. Epub 2012 Aug 11.

  PMID: 22889720 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: June 1, 2011
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (3)