Purines for rapid identification of stroke mimics
| ISRCTN | ISRCTN22323981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22323981 |
| Secondary identifying numbers | 39937 |
- Submission date
- 28/01/2019
- Registration date
- 13/02/2019
- Last edited
- 13/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Currently, without specialist hospital assessments and tests, it can be difficult to tell the difference between a stroke and some other illness that have symptoms like stroke. Other illnesses which have symptoms like stroke are called ‘stroke mimic’ conditions. Examples of stroke mimic conditions are some infections and migraine. The treatments for a stroke and a ‘stroke mimic’ condition are very different. This can be treatment in different hospital departments or even in completely different hospitals. This is because some urgent stroke treatments are only available in very specialised regional hospitals. Because it can be difficult to tell the difference between stroke and stroke mimic conditions, ambulance staff sometimes take people to a less appropriate location initially. This means that some patients have to be transferred between hospital departments or to a second hospital after initial assessments have been conducted at the first hospital a person was taken to. This can result in delays to emergency treatment for patients suffering both types of illness. This study is evaluating a quick and easy new finger prick blood test which may help to rapidly tell the difference between a stroke and a stroke mimic condition. The test is small and portable so that it can be used in ambulances as well as in hospital.
Who can participate?
Patients aged 18 and over with symptoms of suspected stroke
What does the study involve?
Participants undergo the new test and all routine tests which would be conducted to investigate suspected stroke symptoms. The results of the new test are compared with routine tests to determine if this new test is useful. The first finger prick test takes place in the emergency ambulance by staff trained to perform the test. The test involves a finger prick to obtain a sample of blood which is then placed onto a strip (called ‘SMARTChip’). The other end of the strip is placed into a device. The reading is not available to the staff or patients as is typical in this type of study to evaluate a new test. Following arrival at hospital, some of the patients undergo a second finger prick test conducted by trained hospital research support staff or a trained member of the routine clinical team. The second test is done wherever the patient is located on arrival at hospital, most likely the emergency department or the acute stroke unit. Routine clinical data required for the study are collected. There is no study-specific data collection.
What are the possible benefits and risks of participating?
This study is being conducted to see whether a new test may be useful for telling the difference between a stroke and a stroke mimic condition. If the new test works, in the future it could be used as part of routine ambulance assessments to enable staff to make a distinction between stroke and stroke mimic conditions. Patients could be transported immediately to the most appropriate location for care. There are no direct benefits to individuals who take part in the study. However, it is hoped that care for future patients will be improved as a result of this research. There should be no disadvantages for individuals taking part in this study and the treatment an individual receives will not change. The new test will involve pricking one or two fingers which may be slightly uncomfortable but should not cause any ongoing irritation or discomfort. If there are any ongoing problems, these will be addressed as part of the patient’s routine clinical care. There should be no disadvantages for individuals taking part in this study and the treatment an individual receives will not change.
Where is the study run from?
Participating Hospitals:
1. Northumbria Specialist Emergency Care Hospital (UK)
2. Salford Royal Hospital (UK)
3. Royal Blackburn Hospital (UK)
4. Royal Stoke University Hospital (UK)
Participating Ambulance Services (HQ):
1. North East Ambulance Service NHS Foundation Trust (UK)
2. North West Ambulance Service NHS Trust (UK)
3. West Midlands Ambulance Service NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2018 to March 2021
Who is funding the study?
Innovate UK
Who is the main contact?
1. Dr Anne Oyewole
Anne.oyewole@ncl.ac.uk
2. Dr Chris Price
C.I.M.Price@ncl.ac.uk
3. Dr Lisa Shaw
lisa.shaw@ncl.ac.uk
Contact information
Scientific
Stroke Research Group
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
 ORCID ID |
0000-0002-3435-9519 |
|---|---|
| Phone | +44 (0)191 208 3826 |
| lisa.shaw@ncl.ac.uk |
Scientific
Stroke Research Group
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
| ORCID ID |
0000-0003-3566-3157 |
|---|---|
| Phone | +44 (0)191 208 7926 |
| C.I.M.Price@ncl.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Purines for Rapid Identification of Stroke Mimics (PRISM): a diagnostic accuracy study |
| Study acronym | PRISM |
| Study hypothesis | This study aims to determine whether a portable point of care purine assay using a finger-prick blood sample can differentiate between stroke and stroke mimic conditions. |
| Ethics approval(s) | North East - Newcastle & North Tyneside 1 Research Ethics Committee, NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, Tel: +44 (0)2071048083, Email: nrescommittee.northeast-newcastleandnorthtyneside1@nhs.net, 24/12/2018, ref: 18/NE/0307 |
| Condition | Stroke |
| Intervention | This research project is an observational cohort study to evaluate whether blood purine levels measured using a new finger prick blood test (called SMARTChip Purine assay) may differentiate between stroke and stroke mimic conditions. The project also involves a sub-study to evaluate whether blood purine levels may also be useful for helping to diagnose a more serious stroke being caused by blockage of a large blood vessel. Participants will undergo either one or two finger prick blood tests, and all routine tests to investigate suspected stroke. The first finger prick test will be undertaken in the emergency ambulance by staff trained to perform the test. Patients whom ambulance staff consider have suspected stroke symptoms which commenced within 4 hours are suitable to undergo the test provided that they are being conveyed to a hospital taking part in the study. The test involves a finger prick to obtain a sample of blood which is then placed onto a strip containing the purine analysing agents (called ‘SMARTChip’). The other end of the strip is placed into a bespoke reader device which stores the data about the purine level. The purine reading will not be available to the staff or patients as is typical in this type of study to evaluate a new diagnostic test. Following arrival at hospital, some patients will fulfil the additional eligibility criteria for the sub-study (symptom onset within 6 hours, assay can be undertaken before reperfusion treatments). These patients will undergo a second finger prick test at this stage. The second test will be conducted by trained hospital research support staff or a trained member of the routine clinical team. The second test will be done wherever the patient is located on arrival at hospital. Most likely this will be the emergency department or the acute stroke unit. Following consent to enter the study, routine clinical data required for the study analyses will be collected. There is no study specific data collection. Reference standard tests: Expert clinical opinion informed by brain imaging and/or other investigations will assign the following reference standard diagnoses at 7 days: ischaemic stroke, haemorrhagic stroke, TIA, stroke mimic conditions. Index test: Purine measurement data will be harvested from the bespoke purine readers. Pre-hospital and hospital routinely collected data are required for this study. Ambulance staff will complete a short study specific proforma which they will leave at hospital with the new test equipment (test equipment and hospital interaction described earlier). Hospital research support staff will transcribe routinely available hospital data onto the research paperwork/online database. Copies of some images (e.g. CT scans) are also required for the study and these will be provided to the research team on a CD or in an electronic format as systems allow. All data will be provided to the research team using pseudoanonymised number codes only. For the majority of participants, hospital research support staff or a trained member of the clinical team will obtain consent on the hospital ward where the patient is located. However, if a participant is discharged before consent can be obtained, a postal invitation letter and consent form will be used. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Sensitivity, specificity, negative and positive predictive values, and area under the Receiving Operating Curve (ROC) calculated using purine readings (SMARTChip Purine assay) and results of reference standard tests. Timepoint(s): tests conducted in the emergency ambulance and on arrival at hospital |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2018 |
| Overall study end date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 958; UK Sample Size: 958 |
| Participant inclusion criteria | Trained ambulance personnel (paramedics or technicians) responding to an emergency call will attempt a finger prick reading on patients that fulfil the following criteria: Inclusion criteria: 1. Aged 18 years and over 2. At least responsive to strong stimuli during assessment of conscious level (A, V or P on the AVPU scale) 3. Face Arm Speech Test (FAST) positive or any observed new focal neurological symptoms indicating suspected acute stroke in the ambulance personnel's clinical judgement 4. Persistence of the new stroke-like symptoms during the initial clinical assessment 5. Believed to be within 4 hours of the new stroke-like symptoms at the time of the first clinical assessment 6. Will be transported to a study hospital In order to provide the population to fulfil the objectives of the substudy, trained hospital staff (when available) will attempt a reading on the following subgroup of patients: 1. Had an assay reading attempted by ambulance personnel (whether successful or not) 2. The symptoms resulting in admission are believed to have commenced within 6 hours of the time that the hospital assay can be performed 3. The hospital assay can be performed before intravenous thrombolysis or mechanical thrombectomy if this treatment is indicated |
| Participant exclusion criteria | Exclusion criteria for the ambulance finger prick reading are: 1. Hypoglycaemia (capillary glucose < 3.5mmol/l) 2. External signs of significant acute trauma which are likely to need additional treatment (large haematomas, open wounds, limb deformity) 3. Currently receiving chemotherapy or radiotherapy treatment for cancer |
| Recruitment start date | 01/04/2019 |
| Recruitment end date | 30/09/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cramlington
NE23 6NZ
United Kingdom
Salford
M6 8HD
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom
Chorley New Road
Bolton
BL1 5DD
United Kingdom
Waterfront Business Park
Waterfront Way
Brierley Hill
DY5 1LX
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Ms Peta Heslop
Rake Lane
North Shields
NE29 8NH
England
United Kingdom
| Phone | +44 (0)1912934087 |
|---|---|
| Peta.Heslop@northumbria-healthcare.nhs.uk | |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Study results may also be disseminated at national and international academic meetings and conferences. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 20/05/2021 | 24/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 31/03/2021.
2. The plain English summary was updated to reflect these changes.
24/05/2021: Publication reference added.
04/09/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2020 to 30/09/2021.
2. The overall end date was changed from 31/01/2021 to 31/12/2021.
3. The intention to publish date was changed from 31/01/2022 to 30/06/2022.
4. The plain English summary was updated to reflect these changes.
09/10/2019: The primary contact was changed from Dr Anne Oyewole to Dr Lisa Shaw.
