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Asymptomatic Carotid Stenosis: Cognitive Function and Plaque Correlates (ACCOF)

This study is ongoing, but not recruiting participants.
George Mason University
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: May 11, 2011
Last updated: April 19, 2017
Last verified: April 2017
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.

Cognitive Manifestations

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Asymptomatic Carotid Stenosis: Cognitive Function and Plaque Correlates

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • composite cognitive score [ Time Frame: 2 years ]
    composite of multiple cognitive function test scores

Biospecimen Retention:   Samples With DNA
blood samples for inflammatory markers

Estimated Enrollment: 284
Actual Study Start Date: May 15, 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
carotid stenosis
no stenosis
no stenosis

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients eligible for the study will have asymptomatic >=50% carotid stenosis

Inclusion Criteria:

  • asymptomatic 50% carotid stenosis or more

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01353196

United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
George Mason University
Principal Investigator: Brajesh K Lal, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT01353196     History of Changes
Other Study ID Numbers: CARA-024-10S
Study First Received: May 11, 2011
Last Updated: April 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
cognitive function

Additional relevant MeSH terms:
Carotid Stenosis
Neurobehavioral Manifestations
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 24, 2017