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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by VA Office of Research and Development
Sponsor:
Collaborator:
George Mason University
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01353196
First received: May 11, 2011
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
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.

Condition
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 ] [ Designated as safety issue: No ]
    composite of multiple cognitive function test scores


Biospecimen Retention:   Samples With DNA
blood samples for inflammatory markers

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

  Show Detailed Description

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01353196

Contacts
Contact: Brajesh K Lal, MD (410) 605-7000 blal@smail.umaryland.edu

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Miriam J Smyth, PhD    410-605-7130    miriam.smyth@va.gov   
Principal Investigator: Brajesh K Lal, MD         
Sponsors and Collaborators
VA Office of Research and Development
George Mason University
Investigators
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
ClinicalTrials.gov Identifier: NCT01353196     History of Changes
Other Study ID Numbers: CARA-024-10S 
Study First Received: May 11, 2011
Last Updated: October 21, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
carotid
atherosclerosis
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

ClinicalTrials.gov processed this record on December 02, 2016