N/A
N=170
Asymptomatic Carotid Stenosis: Cognitive Function and Plaque Correlates
Cognitive Manifestations
Bottom Line
View on ClinicalTrials.gov: NCT01353196 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Composite Cognitive Score — 45.5; 47.9 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Cognitive Score |
45.5; 47.9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01353196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.