ISRCTN ISRCTN83802006
DOI https://doi.org/10.1186/ISRCTN83802006
IRAS number 328197
Secondary identifying numbers IRAS 328197
Submission date
22/01/2024
Registration date
01/02/2024
Last edited
06/06/2025
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
We have seen a doubling in the number of new stroke cases in adults under the age of 55 years in the last 10 years in the UK and in other high-income countries. However, the reasons for this increase remain unclear. The aim of this study is to find out how traditional stroke risk factors that are more common at older ages, such as high blood pressure, diabetes, high cholesterol level, smoking and obesity, might contribute to the occurrence of stroke at younger ages. The researchers are also hoping to find out if emerging stroke risk factors also play a role in the rising number of young stroke cases, such as long working hours, stress and mental health conditions.

Who can participate?
Adult patients aged between 18-54 years with diagnosed stroke

What does the study involve?
The study will involve a short questionnaire (about 30 minutes) through an interview with the local study team, where they will collect information on participants' past medical history, lifestyle-related factors, family history, birth history, and other stroke risk factors. The research team will also collect relevant information about the stroke episode. The interview can be done face-to-face during the hospital stay or by phone after participants are discharged. All patients will undergo centralised administrative follow-up via record linkage for up to 30 years.

What are the possible benefits and risks of participating?
The study only includes a short questionnaire and there are no unlikely foreseeable risks associated.

Where is the study run from?
Oxford University (UK)

When is the study starting and how long is it expected to run for?
October 2023 to December 2056

Who is funding the study?
1. Oxford University (UK)
2. Oxford BRC (UK)
3. Wellcome Trust (UK)

Who is the main contact?
Dr Linxin Li, linxin.li@ndcn.ox.ac.uk

Contact information

Dr Linxin Li
Public, Scientific, Principal Investigator

Wolfson Centre for Prevention of Stroke and Dementia
Wolfson Building
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0002-3636-8355
Phone +44 (0)1865 611277
Email linxin.li@ndcn.ox.ac.uk

Study information

Study designProspective cohort study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typePrevention, Quality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleNational Young Stroke Study
Study acronymNYSS
Study objectivesThe primary objectives of this study are to provide up-to-date and reliable estimates of the associations of traditional modifiable risk factors and emerging risk factors and young stroke.
Ethics approval(s)

Approved 22/01/2024, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8278; gmsouth.rec@hra.nhs.uk), ref: 24/NW/0003

Health condition(s) or problem(s) studiedStroke
InterventionThe study will involve a short questionnaire (about 30 minutes) through an interview with the local study team, where they will collect information on participants' past medical history, lifestyle-related factors, family history, birth history, and other stroke risk factors. The research team will also collect relevant information about the stroke episode. The interview can be done face-to-face during the hospital stay or by phone after participants are discharged. All patients will undergo centralised administrative follow-up via record linkage for up to 30 years.
Intervention typeOther
Primary outcome measure1. Traditional vascular risk factors (e.g. hypertension, diabetes, hyperlipidaemia, obesity, smoking, alcohol excess) measured using questionnaire/medical records at baseline
2. Emerging risk factors (e.g. depression, anxiety and other mental health conditions, long working hours, stress, autoimmune conditions, oral health) measured using questionnaire/medical records at baseline
Secondary outcome measures1. Long-term vascular (recurrent stroke, myocardial infarction, dementia and vascular death) and non-vascular outcomes (cancer and mental health conditions) measured using medical record linkage at 5, 10, 20 and 30 years
2. Stroke severity measured using National Institutes of Health Stroke Scale (NIHSS) at baseline
3. Disability measured using modified Rankin scale at baseline in the first instance
4. Quality of life measured using EQ-5D at baseline in the first instance
Overall study start date01/10/2023
Completion date31/12/2056

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit54 Years
SexBoth
Target number of participants2000
Key inclusion criteria1. Patient is willing and able to give informed consent for participation in the study, or favourable consultee advice for adults lacking capacity
OR
If consent or consultee advice was not feasible, CAG/Section 251 support for data collection
2. Male or Female, aged 18 to 54 years
3. A diagnosis of ischaemic stroke (including retinal artery occlusion)
OR
A diagnosis of intracerebral haemorrhage
Key exclusion criteria1. Intracerebral haemorrhage as a result of trauma
2. Ischaemic stroke or intracerebral haemorrhage as a result of cerebral venous thrombosis
Date of first enrolment01/10/2025
Date of final enrolment31/12/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Thames Valley & South Midlands CRN
N/A
United Kingdom
North East and North Cumbria CRN
N/A
United Kingdom
North West Coast CRN
N/A
United Kingdom
Yorkshire and Humber CRN
N/A
United Kingdom
Greater Manchester CRN
N/A
United Kingdom
East Midlands CRN
N/A
United Kingdom
West Midlands CRN
N/A
United Kingdom
West of England CRN
N/A
United Kingdom
East of England CRN
N/A
United Kingdom
Kent, Surrey and Sussex CRN
N/A
United Kingdom
Wessex CRN
N/A
United Kingdom
South West Peninsula CRN
N/A
United Kingdom
North Thames CRN
N/A
United Kingdom
South London CRN
N/A
United Kingdom
North West London CRN
N/A
United Kingdom
Wolfson Centre for Prevention of Stroke and Dementia, NDCN, Oxford University
Wolfson Building
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

University of Oxford
University/education

Research Governance, Ethics and Assurance
Boundary Brook House
Churchill Drive
Oxford
OX3 7GB
England
United Kingdom

Phone +44 (0)1865-289885
Email RGEA.Sponsor@admin.ox.ac.uk
Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

University/education

University of Oxford
Private sector organisation / Universities (academic only)
Alternative name(s)
St Cross College, University of Oxford
Location
United Kingdom
NIHR Oxford Biomedical Research Centre
Private sector organisation / Research institutes and centers
Alternative name(s)
NIHR Biomedical Research Centre, Oxford, OxBRC
Location
United Kingdom
Wellcome Trust
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Wellcome, WT
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2029
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data-sharing plans for the current study are currently under development and will be made available at a later date.

Editorial Notes

06/06/2025: The recruitment start date was changed from 01/06/2025 to 01/10/2025.
21/01/2025: The recruitment start date was changed from 01/01/2025 to 01/06/2025.
08/10/2024: The recruitment start date was changed from 01/10/2024 to 01/01/2025.
09/09/2024: The recruitment start date was changed from 01/09/2024 to 01/10/2024.
30/05/2024: The recruitment start date was changed from 01/04/2024 to 01/09/2024.
22/01/2024: Study's existence confirmed by the North West - Greater Manchester South Research Ethics Committee.