Brief summary describing the background
and objectives of the trial
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Background:
Cerebral small vessel disease is a disorder of the brain’s small perforating arterioles, capillaries, and probably venules, that causes various lesions that are seen on pathological examination or brain imaging with MRI or CT (wardlaw 2019).
These lesions might be clinically silent individually, and many affected people do not have symptoms, but increasing numbers of individual lesion types and combinations of lesion types are associated with cognitive impairment, dementia, depression, mobility problems, increased risk of stroke, and worse outcome after stroke.
Since White Matter Hyperintensities (WMH) progression is associated with clinical consequences, WMH progression may be used as a surrogate marker in preventive trials. Several longitudinal studies with serial MRI investigated the risk factors for WML progression (Mok and Kim, 2015).
The proposed study is a longitudinal, single-blind, randomized clinical trial in which 220 patients with incidental cerebral small vessel disease will be recruited over the course of one year. Patients will be divided into two groups, the first receiving aspirin 150 mg/day and the second receiving cilostazol 200 mg/day.
At baseline there will be clinical assessment using cognitive scales (MoCA, BMET, BDI), motor scales (10 MW test, Time up and Go, Berg Balance Scale), urinary assessment using ICIQ, and radiological assessment MRI brain done for all patients
Follow-up with patients will be done after one year to compare clinical and radiological progression between the two groups.
Objectives of the trial:
The primary aim of this study is to compare the outcome of cognitive performance, gait function, and sphincteric affection in SVD patients between the patient group receiving aspirin and the group receiving cilostazol.
The secondary aim of this study is to compare the progression of the white matter intensities, lacunes, microbleeds, and brain atrophy in the studied groups.
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