Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

Carotid Artery Stenosis Clinical Trial

Official title:

Long-term Neurocognitive Sequelae of Subclinical Microembolization During Carotid Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718600
• Other study ID #: R01NS070308
• Status: Completed
• Start date: June 2011
• Est. completion date: April 2018

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Behavioral:
• Neuropsychological testing

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin
United States	Palo Alto Veterans Affairs	Palo Alto	California
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	University of Wisconsin, Madison, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of microemboli in correlation with changes in neurocognitive assessment performance		1 year following CAS procedure
Secondary	Risk factor stratification for incidence of microemboli		1 year following CAS procedure