Abstract
BackgroundThis paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH) lesions and silent brain infarction (SBI). Additional aims include determining whether a) changes in retinal vascular imaging (RVI) parameters parallel changes in brain magnetic resonance imaging (MRI); b) changes in RVI parameters are observed with aspirin therapy; c) baseline cognitive function correlates with MRI and RVI parameters; d) changes in cognitive function correlate with changes in brain MRI and RVI and e) whether factors such as age, gender or blood pressure influence the above associations.Methods/DesignDouble-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis.DiscussionThis study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline.Trial Registrationclinicaltrials.gov Identifier: NCT01038583
Highlights
This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH) lesions and silent brain infarction (SBI)
While the Aspirin in Reducing Events in the Elderly (ASPREE) trial will address the question of whether low-dose aspirin can prevent death or the onset of disability, including dementia and cognitive decline, over a 5-year period in people 70 years and over, the ENVIS-ion sub-study provides a unique opportunity to examine whether regular low-dose aspirin reduces the rate of increase of brain Magnetic Resonance Imaging (MRI)-measured WMH and Silent brain infarcts (SBI) volumes
The trial will investigate if changes in RVI parameters parallel brain MRI changes over 3 years and explore the value of MRI and RVI in assessing and defining vascular changes and cognitive function
Summary
The ENVIS-ion study will add to the current knowledge in the field by identifying whether aspirin treatment can influence the development and progression of white matter hyper-intensities which in-turn influence cognitive function. It will determine whether retinal vascular imaging, a much less expensive approach, may be an alternative approach to MRI measurement. This may result in a low cost alternative to identify whether older people who may benefit from aspirin therapy, should be treated. The ENVIS-ion trial will significantly inform global efforts to maximize our abilities to “maintain the brain” and, in addition, may improve the understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function
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