The Young ESUS Study

• Research type

  Research Study

• Full title

  Longitudinal Study of Young Patients with Embolic Stroke of Undetermined Source (ESUS)

• IRAS ID

  228541

• Contact name

  Roland Veltkamp

• Contact email

  roland.veltkamp@imperial.nhs.uk

• Sponsor organisation

  Population Health Research Institute of McMaster University and Hamilton Health Sciences Centre

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  Design: Investigator Initiated Longitudinal Prospective Observational Patient study
  Background: Around 20% of strokes are investigated and no cause found. It has been suggested that these can be characterised as ‘Embolic Stroke of Undetermined Source’ or ESUS. Currently little is known about this type of stroke, especially in young people.
  Aims: The purpose of the registry is to better understand the characteristics of ESUS in young patients, to determine; how often a second stroke occurs; mortality rate; and if possible what factors contribute to a second stroke.
  Population and Location: We will recruit between 500-1000 patients from approximately 100 hospitals in 13 countries around the world. Between 80- 130 of these patients are expected to be recruited in the UK across 13 sites.
  Methods: Patients will be approached when they are in hospital or when they are seen in stroke follow up clinics. If they consent to take part then information about them and their stroke will be collected in a short interview and from their medical notes. Patients will be contacted by telephone every 6 months, up to 18 months post stroke. The follow up phone calls will be brief and will just be to see how they are recovering from their stroke and if they have had any further events or relevant new diagnosis. The patients recruited will not undergo any additional treatment, diagnostic tests or have any change in their medical care due to taking part.
  Eligibility: Patients aged 21-50 who have been diagnosed with a stroke for which no clear cause was found; the medical term for this is an ‘Embolic Stroke of Undetermined Source’ or ESUS.
  Funder: Bayer AG
  Sponsor: Population Health Research Institute (PHRI)
  UK Sponsor Representative: Imperial College London

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  17/EE/0324

• Date of REC Opinion

  10 Oct 2017

• REC opinion

  Further Information Favourable Opinion