None listed
Conditions
Brief summary
Changes to the small cerebral blood vessels are commonly obeserved on brain MRIs of the elderly. Two common changes observed are cerebral microhaemorrhages (CMH), which have been reported in 10-60% of healthy elderly subjects, and areas of white matter hyperintensity (WHI). The clinical significance of CMH remains uncertain, though there is a possibility they could predipose to later, clinically overt, haemorrhages. There have been mixed reports, derived from cross-sectional and longitudinal studies, on whether long-term low-dose aspirin increases the risk of CMH but this has not been evaluated in the context of a clinical trial. This study will investigate whether daily low dose aspirin increases the number of CMH after one and three years, as measured on brain MRI, as well as determine whether daily low dose aspirin changes the volume of WHI over the same time period, whether the presence of CMH on MRI at baseline is associated with subsequent incidence of ischaemic and haemorrhagic stroke and cognitive decline, and will also correlate imaging biomarkers measured with MRI with cognitive and clinical outcomes over three years.
Interventions
This study is a sub-study of the Aspirin in Reducing Events in the Elderly study (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org). ASPREE is a double blinded, randomised controlled trial of low dose aspirin, 100mg oral tablets versus placebo, taken daily for a mean of five years in healthy participants aged 70 and over, followed over a mean of five years for the primary outcomes of dementia-free survival and disability-free survival. It is a primary prevention study.
This study is a sub-study of the Aspirin in Reducing Events in the Elderly study (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org). ASPREE is a double blinded, randomised controlled trial of low dose aspirin, 100mg oral tablets versus placebo, taken daily for a mean of five years in healthy participants aged 70 and over, followed over a mean of five years for the primary outcomes of dementia-free survival and disability-free survival. It is a primary prevention study. The ASPREE NEURO substudy will involve a subset of newly enrolling participants in the parent ASPREE study based in Melbourne. At the ASPREE randomisation visit ASPREE participants will be given information on the ASPREE NEURO substudy and will later be screened for any contraindication to MRI. Participants will undergo a non contrast 3 Tesla brain MRI early after entry into the ASPREE study, and again at year 3. The MRI study will include T1 and T2 weighted images, diffusion weighted imaging and SWI. Participants will now also be invited to undergo an additional non contrast 3 Tesla Brain MRI, utilising the same MRI protocol, 1 year after their baseline image.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Enrolling into the ASPREE study in Melbourne Aged 70 and over Able and willing to provide informed consent
Exclusion criteria
Exclusion criteria for ASPREE: History of diagnosed cardiovascular event, including MI and stroke, atrial fibrillation, serious intercurrent illness likely to cause death within 5 years, cognitive impairment or dementia, disability, anaemia, a current or recurrent condition with a high risk of major bleeding, absolute contradindication or allergy to aspirin. Additional exclusion criteria for this study: Any contraindication to MRI scanning (e.g. implanted pacemaker, presence of metal in eye, claustrophobia, cerebral aneurysm clip).
Outcome results
None listed