This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

R4VaD - Rest of UK

  • Research type

    Research Study

  • Full title

    Rates, Risks and Routes to Reduce Vascular Dementia (R4VaD)

  • IRAS ID

    244590

  • Contact name

    Joanna M Wardlaw

  • Contact email

    joanna.wardlaw@ed.ac.uk

  • Sponsor organisation

    University of Edinburgh

  • ISRCTN Number

    ISRCTN18274006

  • Duration of Study in the UK

    4 years, 8 months, 0 days

  • Research summary

    Stroke commonly affects cognition and, by definition, vascular dementia is driven by stroke disease in some way. However, fundamental knowledge about risk factors is widely acknowledged to be missing, restricting mechanistic understanding, prevention, treatment, and design of patient services. We aim to recruit a wide range of patients with stroke, presenting to geographically diverse UK hospitals, into a longitudinal study to determine rates of, and risk factors for, cognitive and related impairments after stroke, to assess mechanisms and improve prediction models. We will recruit about 2000 patients within a few weeks of stroke, collect patient, stroke, socioeconomic, lifestyle, cognitive (plus fatigue, mood) and informant data using streamlined methods appropriate to the stroke stage. We will obtain more detailed assessments at 6+/- 2 weeks post baseline assessment and follow-up by phone and post yearly to at least 2 years. We will assess diagnostic neuroimaging, vascular function, high-sensitivity inflammatory markers and genetic associations. Outputs will include reliable data on cognition long-term after stroke, stratified by prior cognition, stroke and patient-related variables, improved risk prediction and understanding the influence of neuroimaging, vascular, inflammatory and genetic markers. Participants will be in follow-up and consented for re-contact, facilitating future clinical trials. [COVID 19 amendment 22/04/2020] The main amendment to the study is to include a COVID-19 substudy, in which information regarding COVID-19 will be collected for patients recruited to R4VaD. Additional information on COVID-19 status and treatment will be collected for all patients at baseline (24 hours to 6 weeks post stroke), and at the follow-up assessment (4-8 weeks after the baseline assessment). We will also collect information on risk factors for COVID-19, and any additional relevant laboratory or radiological investigations. The baseline assessment will be streamlined to reduce the overall length of the assessment. We have not amended the currently approved protocol, but have made an addendum to the original protocol. For this substudy patients will be recruited from any inpatient ward, including COVID-19 wards and ITUs. It is likely that many of these patients will be very ill and lack the capacity to consent to research. In light of current restrictions on acute hospital wards, it may not be possible to obtain an opinion quickly enough from a consultee, relative, friend or welfare attorney. In these cases, we will use a waiver of consent, whereby the clinical team will make the decision\nas to whether a patient is enrolled into the study. For this we have amended the nominated consultee consent form which will be completed by a member of the medical team to document the patients enrollment into the study. We will then seek informed consent from the patient or an opinion from a consultee either later during admission or at the follow up assessment. Should a participant indicate in any way that they do not wish to be involved in the study, they will be withdrawn. This substudy will allow the evaluation of the impact of the current COVID-19 pandemic on patients with stroke, data for which are currently lacking. This is important as early research from China suggests that patients with cerebrovascular disease are at increased risk of COVID-19 and may have worse outcomes. R4VaD has existing funded infrastructure already in place, with research practitioners who already familiar with the procedures. It been recruiting for over a year, and has planned long term follow up of up to 10 years, therefore this substudy will also allow evaluation of patients before, during and after the pandemic. Changes to the consent process for adults lacking capacity will also allow us to collect data on strokes of all severities and different stages of COVID-19, even those who are intubated. [COVID-19 Amendment 22/04/2020] The main amendment to the study is to include a COVID-19 substudy, in which information regarding COVID-19 will\nbe collected for patients recruited to R4VaD. Additional information on COVID-19 status and treatment will be collected for all patients at baseline (24 hours to 6 weeks post stroke), and at the follow-up assessment (4-8 weeks after the baseline assessment). We will also collect information on risk factors for COVID-19, and any additional\nrelevant laboratory or radiological investigations. The baseline assessment will be streamlined to reduce the overall length of the assessment. We have not amended the currently approved protocol, but have made an addendum to the original protocol. For this substudy patients will be recruited from any inpatient ward, including COVID-19 wards and ITUs. It is likely that many of these patients will be very ill and lack the capacity to consent to research. In light of current restrictions on acute hospital wards, it may not be possible to obtain an opinion quickly enough from a consultee, relative, friend or welfare attorney. In these cases, we will use a waiver of consent, whereby the clinical team will make the decision as to whether a patient is enrolled into the study. For this we have amended the nominated consultee consent form which will be completed by a member of the medical team to document the patients enrollment into the study. We will then seek informed consent from the patient or an opinion from a consultee either later during admission or at the follow up assessment. Should a participant indicate in any way that they do not wish to be involved in the study, they will be withdrawn. This substudy will allow the evaluation of the impact of the current COVID-19 pandemic on patients with stroke, data for which are currently lacking. This is important as early research from China suggests that patients with cerebrovascular disease are at increased risk of COVID-19 and may have worse outcomes. R4VaD has existing funded infrastructure already in place, with research practitioners who already familiar with the procedures. It been recruiting for over a year, and has planned long term follow up of up to 10 years, therefore this substudy will also allow evaluation of patients before, during and after the pandemic. Changes to the consent process for adults lacking capacity will also allow us to collect data on strokes of all severities and different stages of COVID-19, even those who are intubated.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    18/NE/0150

  • Date of REC Opinion

    26 Jul 2018

  • REC opinion

    Further Information Favourable Opinion