Improving stroke diagnosis: A study using blood tests and clinical information to quickly identify stroke types in suspected stroke patients
| ISRCTN | ISRCTN35174477 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35174477 |
| IRAS number | 351335 |
| Secondary identifying numbers | MR/X502868/1 |
- Submission date
- 27/01/2025
- Registration date
- 04/02/2025
- Last edited
- 14/07/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is a leading cause of death and disability worldwide. Early and accurate diagnosis of stroke subtypes, such as bleeding in the brain (intracerebral haemorrhage, ICH) or a blocked blood vessel (large vessel occlusion, LVO), is critical to ensuring timely treatment and better outcomes. Current tools like the Face Arm Speech Test (FAST) are unable to reliably identify these subtypes, leading to delays in care. This study aims to develop and test a new diagnostic tool that combines clinical observations with a quick blood test (the LVOne test) to improve the diagnosis of stroke subtypes shortly after hospital arrival.
Who can participate?
Adults aged 18 or older who are brought to the hospital by ambulance with symptoms of a possible stroke that started within the last six hours are eligible to participate. Patients who have had recent injuries or conditions that could affect the test results may not be eligible.
What does the study involve?
Participants will have a small blood sample taken through a finger prick and, when possible, an additional sample from a routine blood draw. The blood samples will be tested using the LVOne test to measure levels of specific markers associated with stroke subtypes. Clinical data and brain imaging results will also be collected. The results of the blood test will not influence the patient’s treatment but will be compared to final diagnoses to evaluate the tool's accuracy.
What are the possible benefits and risks of participating?
There are no direct benefits to participants, but the study may improve future stroke diagnosis and care. Risks are minimal, with a small chance of discomfort or bruising from the finger prick or additional blood samples.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
May 2024 to December 2026
Who is funding the study?
The study is funded by the Translation Manchester Accelerator Awards and the University of Manchester (UK)
Who is the main contact?
Prof Adrian Parry-Jones, adrian.parry-jones@manchester.ac.uk
Contact information
Public, Scientific, Principal Investigator
Clinical Sciences Building, Salford Royal Hospital, Stott Lane, Salford
Manchester
M6 8HD
United Kingdom
 ORCID ID |
0000-0002-4462-3846 |
|---|---|
| Phone | (+44) 161 206 4458 |
| adrian.parry-jones@manchester.ac.uk |
Study information
| Study design | Observational diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic accuracy study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 46756 DIAGNOSIS PIS V1.0 13Jan2025.pdf |
| Scientific title | DIAGnosis using NOvel technology for Subtypes In Stroke (DIAGNOSIS study): performance evaluation |
| Study acronym | DIAGNOSIS |
| Study objectives | Combining clinical features with point-of-care biomarker tests (GFAP and D-dimer) can improve the prehospital differentiation of stroke subtypes, specifically intracerebral hemorrhage (ICH) and large vessel occlusion (LVO), from other suspected stroke cases. This approach has the potential to enable more targeted and timely interventions, improving patient outcomes and resource allocation. |
| Ethics approval(s) | Submitted 13/06/2025, Yorkshire & The Humber - Leeds West Research Ethics Committee (arrow Business Centre, Rolling Mill Road, Jarrow, Tyne and Wear, NE32 3DT, Jarrow, Tyne and Wear, NE32 3DT, United Kingdom; +44 207 1048053; leedswest.rec@hra.nhs.uk), ref: 25/YH/0102 |
| Health condition(s) or problem(s) studied | Differentiation of intracerebral hemorrhage (ICH) and large vessel occlusion (LVO) from other suspected stroke cases in adult patients presenting with stroke-like symptoms. |
| Intervention | This is an observational study with no interventions. The study methodology involves: 1. Collecting clinical features from suspected stroke patients upon hospital arrival, as documented in ambulance and emergency department records. 2. Blood sample collection: - Fingerprick capillary blood sample for the LVOne test. - Venous blood sample (< 4 ml in EDTA tube) for processing and storage. 3. Testing using UpFront Diagnostics' GFAP and D-dimer lateral flow tests (LVOne test), with results available within 15 minutes. 4. Processing of venous blood samples: - Centrifugation and plasma aliquoting within 4 hours of collection - Freezing of plasma at -80°C for later analysis 5. Comparing diagnostic results from the LVOne test and biomarker analyses with final diagnoses determined through clinical evaluation and brain imaging (CT and/or MRI). The study will be conducted at three major stroke centres in Greater Manchester: Salford Royal Hospital, Fairfield General Hospital, and Stepping Hill Hospital. Participants will be followed up prior to hospital discharge to collect information on final diagnosis and treatment. |
| Intervention type | Other |
| Primary outcome measure | 1. Diagnostic accuracy of models for determining intracerebral haemorrhage (ICH) is measured using point-of-care GFAP and D-dimer tests (LVOne test) at baseline and prior to hospital discharge 2. Diagnostic accuracy of models for determining large vessel occlusion (LVO) is measured using point-of-care GFAP and D-dimer tests (LVOne test) at baseline and prior to hospital discharge 3. Final diagnoses of intracerebral haemorrhage (ICH) are measured using CT/MRI prior to hospital discharge 4. Final diagnoses of large vessel occlusion (LVO) are measured using CT/MRI prior to hospital discharge |
| Secondary outcome measures | 1. Sensitivity, specificity, positive predictive value, and negative predictive value for identifying intracerebral haemorrhage (ICH) and large vessel occlusion (LVO) are measured using the LVOne test (GFAP and D-dimer levels) compared with final diagnoses determined by brain imaging (CT/MRI) at baseline (on hospital arrival) and prior to hospital discharge 2. Diagnostic accuracy metrics of the developed models compared with those of the Face Arm Speech Test (FAST) and other standard diagnostic tools are measured using a retrospective review of ambulance and hospital patient records at baseline (on hospital arrival) to study completion 3. Evidence of the impact of diagnostic models on clinical decision-making, such as changes in treatment pathways or triage decisions, is measured using a retrospective analysis of clinical pathways and decisions documented in patient notes from baseline (on hospital arrival) to study completion |
| Overall study start date | 01/05/2024 |
| Completion date | 15/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 257 |
| Key inclusion criteria | 1. The patient arrived at the study hospital via emergency ambulance. 2. The patient is 18 years of age or older. 3. Ambulance staff suspected a new acute stroke prior to arrival at the hospital. 4. Stroke symptoms began within 6 hours of sample collection (if the onset was not witnessed, the patient was last known to be well less than 6 hours ago). 5. Blood samples can be collected prior to the administration of any treatment. 6. Urgent brain imaging is planned as part of the patient's diagnostic pathway. |
| Key exclusion criteria | 1. The patient was assessed at another hospital and transferred for ongoing care. 2. The patient had a recent diagnosis (within the last 4 weeks) of deep vein thrombosis, pulmonary embolism, arterial embolism, stroke, transient ischaemic attack, long bone fracture, major trauma, or surgery under general anaesthesia, as these conditions may increase D-dimer levels. 3. The patient had a recent head injury (within the last 4 weeks) requiring hospital care, as this may increase GFAP levels. 4. Stroke symptoms started more than 6 hours prior to sample collection. |
| Date of first enrolment | 01/09/2025 |
| Date of final enrolment | 31/08/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Stott Lane
Salford
M6 8HD
United Kingdom
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Sponsor information
University/education
Oxford Rd
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 161 306 6000 |
|---|---|
| elizabeth.j.cartwright@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Other
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be published in peer-reviewed, open-access scientific journals. Additionally, the findings will be presented at national and international conferences focused on stroke care and diagnostics. The study outcomes will also be included in the doctoral thesis of two PhD researchers involved in the project. Efforts will be made to share the findings with relevant healthcare professionals, policymakers, and the general public to inform future stroke diagnosis and treatment practices. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon reasonable request from Prof. Adrian Parry-Jones (adrian.parry-jones@manchester.ac.uk). Details of the data sharing plan: Type of data to be shared: Anonymised clinical data and biomarker test results collected during the study, including diagnostic model outputs and final diagnosis imaging results. Data availability: Data will become available after the study results are published and will remain accessible for a minimum of 5 years. Access criteria: Data will be shared with researchers affiliated with academic or healthcare institutions for the purpose of conducting ethically approved research into stroke diagnosis and management. A data-sharing agreement will be required. Mechanism: Researchers can request access to the data by contacting the primary investigator. Requests will be reviewed by the study team, and approval will be based on alignment with ethical guidelines and data-sharing agreements. Consent and anonymisation: All shared data will be fully anonymised, ensuring no participant can be identified. Participant consent has been obtained for the use and sharing of anonymised data. Ethical and legal restrictions: Data sharing will comply with relevant ethical and legal requirements, including GDPR and the study’s ethical approvals. Anonymisation will ensure privacy and data security. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | independent consultee information version 1.0 |
13/01/2025 | 29/01/2025 | No | No |
| Participant information sheet | version 1.0 | 13/01/2025 | 29/01/2025 | No | Yes |
Additional files
- 46756 DIAGNOSIS PIS V1.0 13Jan2025.pdf
- 46756 DIAGNOSIS independent consultee information V1.0 13Jan2025.pdf
- independent consultee information
Editorial Notes
14/07/2025: The following changes were made to the trial record:
1. The ethics approval was added.
2. The date of first enrolment was changed from 01/07/2025 to 01/09/2025.
3. The date of final enrolment was changed from 30/06/2026 to 31/08/2026.
15/04/2025: The following changes were made:
1. The recruitment start date was changed from 15/04/2025 to 01/07/2025.
2. The recruitment end date was changed from 15/10/2026 to 30/06/2026.
29/01/2025: Trial's existence confirmed by University of Manchester.
