STroke imAging Prevention and Treatment (START): PrePARE Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke

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Stroke and depression are two of the highest ranked diseases in the Burden of Disease rankings of the World Health Organisation. Depression is a common sequela of stroke, with recent estimates between 30-60% of all stroke patients. Depression after stroke is often under diagnosed despite the fact that effective treatment exists. Good predictors of depression that could be used to identify ‘at risk’ patients early as part of the clinical care pathway for stroke currently do not exist. This study aims to investigate the association between poststroke depression and 1) novel imaging markers of brain structure and function as identified by specialized MRI, and 2)functional outcomes including cognition, mood, sensorimotor function, and participation in daily activities. START-PrePARE is an observational cohort study that is part of the START program of study. In addition it will be linked as a sub-study of the START-EXTEND study (NTA 0901), which is a randomised, multicentre, double blinded, placebo controlled phase 3 trial within a larger cohort study of ischaemic stroke patients. START-PrePARE will comprise 100 patients. Participants consented onto the START-PrePARE study will be seen at their hospital at baseline, Day 3-7, 3 months and 12 months for collection of bloods and a series of research tests investigating mood, thinking ability (cognition), diet and lifestyle. The patients will also travel to a central site in Melbourne (the Melbourne Brain Centre), at 3 month and 12 month time points. Here advanced MR imaging, plus more advanced clinical measures of mood, cognition, sensori-motor function and participation will be performed. Investigators and patients will remain blinded to START-EXTEND treatment designation. At Baseline a blood sample will be taken, two brief neurological assessments will be conducted and a medical history will be obtained. 3-7 days following stroke, participants will have another blood test, one brief neurological assessment and three questionnaires conducted asking about their diet and lifestyle and their mood and cognition. At the 3 month and 12 month visits participants will have specialised brain MRI scans which will approximately take 40 minutes plus set up time. They will also be given 10 short assessment tasks and three questionnaires to measure functional outcomes including cognition, mood, and movement as well as participation in household, leisure and social activities and quality of life. These assessments will be administered by a qualified therapist, and will take approximately 120 minutes. The blood test and neurological assessments will be conducted at hospital and the 10 short tasks will be conducted at the Melbourne Brain Centre or at the participant's place of residence if more convenient. All information collected will be recorded without any identifying information and kept private and confidential. An independent Data Safety Monitoring Committee has been set up to monitor safety for START-PrePARE patients for the duration of the trial.