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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mrs
Sharon
Hulme
sharon.hulme@manchester.ac.uk
Craig
Smith
craig.smith-2@manchester.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Cerebrovascular diseasesOrganic, including symptomatic, mental disorders
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Why/what? The overall aim of this project to explore how changes in the immune system, our body's response to injury, relates to cognitive decline after stroke. The project is part of a major international network (Stroke-IMPaCT Network) which aims to identify how the immune system contributes to post-stroke dementia and identify new approaches to its prevention.
Stroke is a major cause of death and disability worldwide. For stroke survivors, one of the most upsetting complications after stroke is a decline in cognitive ability (the ability to think, remember and reason). Cognitive decline occurs in up to a third of stroke survivors within five years of stroke and effects quality of life, ability to work and participate in normal daily activities. As there are no treatments, research to better understand cognitive decline after stroke is a high priority and unmet need.
Who/where? The project will recruit at least 200 stroke survivors from stroke units in Manchester (Salford Royal) and California (Stanford Hospital) and up to 133 non-stroke volunteers of a similar age/sex and with similar risk factors to act as controls. We will invite patients, aged 45 years and over and within four days of stroke, to participate in the study. Those who agree will undergo physical and cognitive tests, including brain imaging at regular intervals for approximately 3½ years after stroke. We will collect blood samples to evaluate changes in the immune system and genetic markers. Brain imaging will measure changes in brain structure over time and these will be compared to blood and brain imaging from non-stroke controls.
How? The project has begun recruitment in Stanford and we will begin recruitment in Salford in early 2021. Recruitment will last for one-two years, with participants in follow-up for at least 3½ years (or longer if funding secured).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Group 1 - Stroke patient-participants: •Pre-existing neurological, psychiatric, or other condition (e.g. complete blindness) that would make it difficult to accurately assess the cognitive outcomes. •Score of 2 points or more on language component of NIHSS score •Unlikely to survive to at least 6 month follow-up or palliative care considered to be imminent •Established diagnosis of dementia predating the stroke •History of haemorrhagic stroke (prior to the index ischaemic stroke) at time of enrolment •Current involvement (or in 30 days prior to initial approach) in a clinical trial of a medicinal product that affects inflammation NOTE: If patient-participants have exclusions to MR scanning they may still participate in main trial but will not undergo MR scanning. Groups 2 – Non-stroke Controls (blood sampling only) •Current treatment with IL-1 blockade or established immune-suppressant therapy (e.g. IL-1Ra or IL-1 antibodies), or treatment within the last 3 months •Currently participating in a clinical trial of investigation medicinal product (CTIMP) or device trial. Group 3 Control participants •History of infection treated with antibiotics in the preceding 6 weeks • Current treatment with IL-1 blockade or established immune-suppressant therapy (e.g. IL-1Ra or IL-1 antibodies), or treatment within the last 3 months •Pre-existing neurological, psychiatric, or other condition (e.g. blindness) that would make it difficult to accurately assess neurologic and/or cognitive outcome. •Currently participating in a clinical trial of investigation medicinal product (CTIMP) or device trial. •Known contraindications to MR scanning (see below) Additional general exclusion criteria for MR scanning: •No known renal impairment based on eGFR < 30 in three months prior to scanning •Not known to be claustrophobic •Able to provide own consent to study participation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Sharon
Hulme
sharon.hulme@manchester.ac.uk
Craig
Smith
craig.smith-2@manchester.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Manchester and funded by FONDATION LEDUCQ .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 49348
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