StrokeSMARTCAPNCT02308605
SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke
An observational study of Stroke, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
Trial summary
The hypothesis is that a stroke causes release of purines from brain into blood and that this is a very early biomarker of brain ischaemia. The investigators propose a simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- SMARTCap
- Type of treatment
- Medical device
- How many people
- 217 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 320
Who may be able to join
- Stroke patients: Admitted to the Hyperacute Stroke Unit having a suspected stroke within 1 hour of admission. Important to note that not all these patients will have suffered a stroke
- Control participants: Relatives of patients admitted to the stroke treatment pathway, who are healthy and have no signs of cardiovascular illness
- Healthy volunteers
Who cannot join
- Stroke patients: Delay in admission exceeds the time window of 4 hours between stroke symptoms and admission
- Control participants: Obvious signs or history of cerebrovascular disease
- Unhealthy volunteers
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
University of Keele
Stoke-on-Trent, ST4 7QB
About this study
Official title: A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology
The hypothesis is that a stroke causes release of purines from brain into blood and that this is a very early biomarker of brain ischaemia. The investigators propose a simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke).
Read the detailed description
In this study, the investigators propose to use newly developed biosensor technology (SMARTCap) to directly address whether purines are indicators of real strokes, and can distinguish strokes from other conditions with similar symptoms, more rapidly.
- Conditions
- Stroke
- Being tested
- SMARTCap
- Keywords
- SMARTCap
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTCapDevice
The Sarissa Biomedical SMARTCap biosensor array. This is an array of biosensors and electrodes in a simple moulded device that will fit into a vacutainer blood tube and will enable the rapid measurement of purines in freshly drawn blood. Therefore, this is not an intervention as such as the device is an In-Vitro Diagnostic Medical Device.
| Study group | Role | What they receive |
|---|---|---|
| Suspected stroke patients and subset | Blood samples taken on admission and at 24 hours, MRI scan between 24 and 48 hours
Subset: Blood samples repeated once per hour for six hours Receives: Device: SMARTCap | |
| Control participants (relatives) | To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients Receives: Device: SMARTCap | |
| Feeding control participants | To donate a baseline blood sample, eat a simple purine rich meal (meat sandwich), then donate 4 more blood samples at 10, 30, 60 and 120 minutes following the meal Receives: Device: SMARTCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the levels of purine in the blood in Stroke patients compared to non-stroke patients (Healthy controls)
Measured: 30 minutes down to 5 minutes
Secondary outcomes (1)
To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans
Measured: 24 hours to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Christopher Imray, University Hospitals Coventry and Warwickshire NHS Trust
- Investigators
- Christopher HE Imray, MB BS FRCP PhD, Principal investigator, University Hospitals Coventry & Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308605
- Sponsor's protocol ID
- CI126414 23 May 2014 V1
- Other IDs
- NIHR
- Acronym
- SMARTCAP
- Status last verified
- Apr 2016
- First submitted
- 3 Oct 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dale N, Tian F, Sagoo R, Phillips N, Imray C, Roffe C. Point-of-care measurements reveal release of purines into venous blood of stroke patients. Purinergic Signal. 2019 Jun;15(2):237-246. doi: 10.1007/s11302-019-09647-4. Epub 2019 Mar 12.
PubMed 30859371
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology
- ClinicalTrials.gov ID
- NCT02308605
- Acronym / sponsor ID
- SMARTCAP / CI126414 23 May 2014 V1
- Conditions
- Stroke
- Keywords
- SMARTCap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that a stroke causes release of purines from brain into blood and that this is a very early biomarker of brain ischaemia. The investigators propose a simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke).
Detailed description
In this study, the investigators propose to use newly developed biosensor technology (SMARTCap) to directly address whether purines are indicators of real strokes, and can distinguish strokes from other conditions with similar symptoms, more rapidly.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected stroke patients and subset | – | Device: SMARTCapBlood samples taken on admission and at 24 hours, MRI scan between 24 and 48 hours Subset: Blood samples repeated once per hour for six hours |
| Control participants (relatives) | – | Device: SMARTCapTo donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients |
| Feeding control participants | – | Device: SMARTCapTo donate a baseline blood sample, eat a simple purine rich meal (meat sandwich), then donate 4 more blood samples at 10, 30, 60 and 120 minutes following the meal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 320
Key inclusion criteria (3 listed)
- Stroke patients: Admitted to the Hyperacute Stroke Unit having a suspected stroke within 1 hour of admission. Important to note that not all these patients will have suffered a stroke
- Control participants: Relatives of patients admitted to the stroke treatment pathway, who are healthy and have no signs of cardiovascular illness
- Healthy volunteers
Key exclusion criteria (3 listed)
- Stroke patients: Delay in admission exceeds the time window of 4 hours between stroke symptoms and admission
- Control participants: Obvious signs or history of cerebrovascular disease
- Unhealthy volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMARTCapThe Sarissa Biomedical SMARTCap biosensor array. This is an array of biosensors and electrodes in a simple moulded device that will fit into a vacutainer blood tube and will enable the rapid measurement of purines in freshly drawn blood. Therefore, this is not an intervention as such as the device is an In-Vitro Diagnostic Medical Device. | Device | Control participants (relatives), Feeding control participants, Suspected stroke patients and subset |
Primary outcome
To measure the levels of purine in the blood in Stroke patients compared to non-stroke patients (Healthy controls)
Time frame: 30 minutes down to 5 minutes
1 secondary outcome
To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans
Time frame: 24 hours to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Derived from this study: PubMed 30859371Dale N, Tian F, Sagoo R, Phillips N, Imray C, Roffe C. Point-of-care measurements reveal release of purines into venous blood of stroke patients. Purinergic Signal. 2019 Jun;15(2):237-246. doi: 10.1007/s11302-019-09647-4. Epub 2019 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher HE Imray, MB BS FRCP PhD principal investigator
University Hospitals Coventry & Warwickshire NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the levels of purine in the blood in Stroke patients compared to non-stroke patients (Healthy controls) (time frame: 30 minutes down to 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.