Asymptomatic Carotid Stenosis: Cognitive Function and Plaque Correlates

NCT01353196 | Completed Results

• 1 other identifier: CARA-024-10S
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Carotid artery plaques are known to cause stroke. Cognitive impairment is an insidious but poorly understood problem in patients with carotid plaques. Cognitive function describes how people perform mental processes such as thinking, learning and problem solving. Asymptomatic carotid plaques may affect 1 million Veterans who may be at risk for cognitive impairment. In this study, the investigators will uncover the extent of cognitive impairment in Veterans with carotid stenosis who are currently labeled "asymptomatic". Programs to prevent or mitigate cognitive impairment will depend on identifying the mechanisms by which this occurs. The investigators will use sophisticated 3D imaging techniques developed by the group to measure the structure and composition of plaques, number of particles breaking off from them, blood levels of chemicals that could disrupt them, and blood flow restriction to the brain from them. This will help identify patients at risk for cognitive impairment who may benefit from preventative measures and improve selection of patients to decrease unnecessary surgical procedures.

Conditions

Cognitive Manifestations

Keywords

carotid; atherosclerosis; cognitive function

Outcome Measures

Primary Outcomes (1)

• Composite Cognitive Score

  composite of multiple cognitive function test scores scores are reported as mean +/- standard deviation 0 = worst 100 = best

  2 years

Study Arms (2)

stenosis

carotid stenosis

no stenosis

no stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients eligible for the study will have asymptomatic \>=50% carotid stenosis

You may qualify if:

• asymptomatic 50% carotid stenosis or more

You may not qualify if:

• previous stroke or transient ischemic attack (TIA)
• severe medical illness that would interfere with evaluation of outcomes or reduce the likelihood of a 2-year follow-up
• carotid occlusion
• patients scheduled for carotid revascularization procedures

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Lal BK, Dux MC, Sikdar S, Goldstein C, Khan AA, Yokemick J, Zhao L. Asymptomatic carotid stenosis is associated with cognitive impairment. J Vasc Surg. 2017 Oct;66(4):1083-1092. doi: 10.1016/j.jvs.2017.04.038. Epub 2017 Jul 14.

  PMID: 28712815 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for inflammatory markers

MeSH Terms

Conditions

Neurobehavioral Manifestations; Atherosclerosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Brajesh K. Lal, MD
• Organization: VA Medical Center VA Maryland Health Care System, Baltimore, MD

blal@som.umaryland.edu

410-605-7000

Study Officials

• Brajesh K Lal, MD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: May 15, 2011
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)