The Assessment of Fluoxetine in Stroke Recovery Imaging and Blood Biomarkers Sub - Study AFFINITY BM

Not Applicable

Completed

• Conditions: stroke; Neurological - Other neurological disorders; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12619000986178
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-11
• Study Completion: 2020-06-05
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Participants may partake of either one or both of the sub studies

Blood Biomarkers sub study:
Participants randomised and participating in the AFFINITY Trial

MRI neuroimaging sub study:
Participants randomised and participating in the AFFINITY Trial
Brain imaging consistent with an ischaemic stroke of either hemisphere
Brain imaging conducted within 21 days of qualifying stroke event

Exclusion Criteria

MRI neuroimaging sub study:
Brain imaging consistent with haemorrhagic (intracerebral and / or subarachnoid) stroke
Contra-indication to having a MRI e.g. implanted pacemaker or severe claustrophobia (these people can still participate in the blood biomarker sub-study)
Unable to undergo follow up MRI at six months

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Activation in the ipsilesional primary motor and medial-premotor cortices [composite primary outcomes] as measured by task-related functional magnetic resonance imaging (MRI) at 6 months.<br>[6 months ];Genetic blood biomarkers of functional neurological recovery, as an exploratory outcome.<br>Markers of interest to be analysed by DNA analysis of the blood include the Apo Ee4 polymorphism, Val66met brain-derived neurotrophic factor (BDNF )polymorphism, and R0 mitochondrial DNA haplotype.<br>[6 months ];Biochemical biomarkers of functional neurological recovery, as an exploratory outcome.<br><br>Markers of interest to be analysed by haematological and biochemical analysis of of the blood include the White cell count, Glucose, C-reactive protein, Interleukin-6, Fibrinogen, <br>N-terminal pro-B-type natriuretic peptide, Heart-type fatty-acid-binding protein, Soluble TNF a receptor-1, and von Willebrand factor<br><br><br><br>[6 months ]

Secondary Outcome Measures

Name	Time	Method
Interhemispheric connectivity of sensorimotor cortices on fMRI[6 months ];Functional connectivity of depression-related brain networks on fMRI[6 months ];Thickness of cortical grey matter in the ipsilesional primary motor cortex on fMRI[6 Months ];Volume of the qualifying stroke lesion on MRI<br>[6 Months ];White matter microstructural integrity on fMRI[6 Months ];Thickness of cortical grey matter in the ipsilesional amygdala on fMRI[6 months ];Thickness of the cortical grey matter in the ipsilesional hippocampus as assessed by MRI scan [6 months ];Connectivity of white matter tracts on fMRI[6 months ]