StrokeNCT02795481
The SMARTChip Stroke Study
An observational study of Stroke, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
Stroke is one of the leading causes of death and disability in the UK and currently costs the country £7bn per year. There is an overwhelming need to accurately and rapidly triage patients to allow best use of finite NHS specialist resources for the treatment of stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 399 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jul 2016to 20 May 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients: adult patients admitted to the hospital experiencing symptoms of stroke at the time of admission Controls: adult patients scheduled to undergo non-vascular, non-oncological surgery at the participating hospital sites Feeding control and spasticity sub-study control participants: Healthy adult members of NHS staff Traumatic brain injury sub-study: Adult patients with an isolated traumatic brain injury.
Who may be able to join
- Aged 18 years or over
- Admitted to hospital with suspected stroke, diagnosed by a suitably qualified doctor or nurse using an appropriate clinical assessment (e.g. FAST, NIHSS, WHO criteria)
- Patient has ongoing symptoms of stroke at the time of enrolment in to the study.
- Aged 18 years and over
- Scheduled for surgery
- Available for follow-up
- Aged 18 years or over
- Admitted to hospital with Traumatic brain injury, diagnosed by a suitably qualified doctor with CT scan supporting evidence of a bleed and/or clot.
Who cannot join
- Onset of stroke symptoms >4.5 hours prior to admission or time of onset of symptoms is not known
- Patient has undergone thrombolysis during current admission (N.B. patients can be enrolled before planned thrombolysis, but not after)
- Patient's stroke symptoms have resolved completely prior to enrolment in the study
- The patient, or their consultee if the patient is incapacitated, is unwilling to provide written informed consent
- Healthy controls
- History of, or evidence of current, cerebrovascular disease, including stroke, transient ischaemic attack, subarachnoid haemorrhage and vascular dementia
Show all 39Show fewer
- History of cardiovascular disease, including myocardial infarction, angina or peripheral vascular disease
- History of, or current, gout
- Currently receiving chemotherapy
- History of diabetes
- Unwilling or unable to provide written informed consent
- Feeding Controls sub-study Inclusion criteria
- Aged 18 years and over
- Member of NHS staff
- Willing to eat the study meal provided (sandwich with a meat based filling)
- Current acute health problems requiring medical review, investigation, or treatment
- History of, or evidence of current, cerebrovascular disease, including stroke, transient ischaemic attack, subarachnoid haemorrhage and vascular dementia
- History of cardiovascular disease, including myocardial infarction, angina or peripheral vascular disease
- History of, or current, gout
- Currently receiving chemotherapy
- History of diabetes
- Unwilling or unable to provide written informed consent
- Spasticity sub-study
- Stroke patients Inclusion criteria - Patients with suspected stroke, who have been enrolled on to the main study at UHNM
- Unwilling or unable to provide written informed consent to the spasticity sub-study
- Controls Inclusion criteria
- Aged 18 years and over
- Member of NHS staff
- Willing to complete follow-up visits
- Current acute health problems requiring medical review, investigation, or treatment
- History of, or evidence of current, cerebrovascular disease, including stroke, transient ischaemic attack, subarachnoid haemorrhage and vascular dementia
- History of cardiovascular disease, including myocardial infarction, angina or peripheral vascular disease
- History of gout
- Currently receiving chemotherapy
- History of diabetes
- Unwilling or unable to provide written informed consent
- Traumatic brain injury sub-study
- The patient, or their consultee if the patient is incapacitated, is unwilling to provide written informed consent
- History of Cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
About this study
Official title: SMARTChip: A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology
Stroke is one of the leading causes of death and disability in the UK and currently costs the country £7bn per year. There is an overwhelming need to accurately and rapidly triage patients to allow best use of finite NHS specialist resources for the treatment of stroke.
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) is proposed. The sensors designed by the investigators are used to measure blood purines during a procedure in which blood flow to the brain is reduced to allow surgical interventions on the major arteries that supply the brain. Previous studies by the investigators have shown that as soon as blood flow to the brain is reduced, purines are produced within minutes and are detectable in systemic arterial blood.
The current project will now compare the levels of purines in the blood of stroke patients and controls. The purines will be measured on admission to hospital and 24 hours later. The occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and 72hrs after admission. This study will establish whether purines are elevated in the blood of stroke patients on admission to hospital compared to healthy controls, and whether this correlates with the size of the stroke and damage to the brain.
Read the detailed description
Stroke patients will be prospectively recruited to the trial on admission to A\&E. The patient will undergo normal clinical assessment and treatment for stroke. As soon after admission as possible, a finger-prick blood sample will be taken from the patient and the SMARTChip device will be used to measure the levels of purines in the sample. A medical history of factors relevant to the purine test will also be established. This will include factors such as any medications that might alter purine levels, a prior history of strokes, diabetes, a history (individual or family) of gout, and when they last had food. The patient will also be given a CT head scan as part of their normal treatment.
In sub-set of patients repeated blood samples (once per hour for 6 hours) will be taken to gain information on how purine levels may change in blood following a stroke. In all patients, the blood purines will be re-tested at 24h (±3h).
All patients will be offered the option of an MRI brain scan at 24-72h post-admission and recruitment will continue until 100 patients with MRI measurements have been enrolled. The flexibility in the timing of the scan is to allow scheduling of the scan to fit in with other demands on the MRI. The purpose of the scan is to identify the nature of the cerebrovascular event and quantify any infarction or area of brain bleeding.
Control participants will give blood on 2 occasions 24h apart for a purine test. The purpose of this control is two-fold: 1) to establish the variability of blood purines in healthy controls and 2) to test whether stroke patients have elevated blood purine levels compared to healthy controls.
Healthy volunteer feeding controls will give a baseline blood sample, eat a simple purine rich meal (a meat sandwich) and then give 4 more blood samples at 10, 30, 60 and 120 minutes following the meal. The purpose of this control is to test whether ingestion of a recent meal might alter baseline blood purine measurements.
Main study patients recruited at University Hospitals North Midlands NHS Trust will also be given the option of participating in the Spasticity and Pharmacokinetic sub-studies. Participants taking part in the Spasticity sub-study will provide an additional blood sample to measure biomarkers and will undergo a spasticity assessment at admission, 24h, 72h, 7d and one or two clinic visits between 30-90d post-admission. Participants taking part in the pharmacokinetic sub-group will provide an additional blood sample for measurement of glutamate and other biomarkers at admission, 24h, 72h, 7d and 30-90d post-admission.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Adult stroke patients with suspected stroke will be recruited on admission to hospital. Recruitment will continue until 100 patients have received an MRI at 24h-72h post admission, up to a maximum recruitment threshold of 300 patients. | |
| Control patients | 50 adult control patients will be recruited from the non-vascular, non-oncological surgical lists at each participating site | |
| Feeding control participants | 15 healthy adult members of NHS staff will be recruited to participate in the feeding control sub-study at University Hospitals Coventry and Warwickshire NHS Trust only. | |
| Spasticity sub-group controls | 10 healthy adult members of NHS staff at University Hospitals of North Midlands, will be recruited to take part as spasticity sub-study controls | |
| Traumatic brain injury patients | 10 adult patients with an isolated traumatic brain injury at University Hospitals Coventry and Warwickshire NHS Trust and Imperial College Healthcare NHS Trust. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether blood purine levels in stroke patients at admission correlate with infarct/ haemorrhage size as determined by MRI or CT scan at 24-72 hours after onset of symptoms
Measured: 24-72h after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start13 Jul 2016
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Imray, PhD, Principal investigator, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795481
- Sponsor's protocol ID
- CI166115
- Status last verified
- Jul 2022
- First submitted
- 6 Jun 2016
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARTChip: A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology
- ClinicalTrials.gov ID
- NCT02795481
- Acronym / sponsor ID
- CI166115
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 10 Jun 2016 (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.
Stroke is one of the leading causes of death and disability in the UK and currently costs the country £7bn per year. There is an overwhelming need to accurately and rapidly triage patients to allow best use of finite NHS specialist resources for the treatment of stroke.
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) is proposed. The sensors designed by the investigators are used to measure blood purines during a procedure in which blood flow to the brain is reduced to allow surgical interventions on the major arteries that supply the brain. Previous studies by the investigators have shown that as soon as blood flow to the brain is reduced, purines are produced within minutes and are detectable in systemic arterial blood.
The current project will now compare the levels of purines in the blood of stroke patients and controls. The purines will be measured on admission to hospital and 24 hours later. The occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and 72hrs after admission. This study will establish whether purines are elevated in the blood of stroke patients on admission to hospital compared to healthy controls, and whether this correlates with the size of the stroke and damage to the brain.
Detailed description
Stroke patients will be prospectively recruited to the trial on admission to A\&E. The patient will undergo normal clinical assessment and treatment for stroke. As soon after admission as possible, a finger-prick blood sample will be taken from the patient and the SMARTChip device will be used to measure the levels of purines in the sample. A medical history of factors relevant to the purine test will also be established. This will include factors such as any medications that might alter purine levels, a prior history of strokes, diabetes, a history (individual or family) of gout, and when they last had food. The patient will also be given a CT head scan as part of their normal treatment.
In sub-set of patients repeated blood samples (once per hour for 6 hours) will be taken to gain information on how purine levels may change in blood following a stroke. In all patients, the blood purines will be re-tested at 24h (±3h).
All patients will be offered the option of an MRI brain scan at 24-72h post-admission and recruitment will continue until 100 patients with MRI measurements have been enrolled. The flexibility in the timing of the scan is to allow scheduling of the scan to fit in with other demands on the MRI. The purpose of the scan is to identify the nature of the cerebrovascular event and quantify any infarction or area of brain bleeding.
Control participants will give blood on 2 occasions 24h apart for a purine test. The purpose of this control is two-fold: 1) to establish the variability of blood purines in healthy controls and 2) to test whether stroke patients have elevated blood purine levels compared to healthy controls.
Healthy volunteer feeding controls will give a baseline blood sample, eat a simple purine rich meal (a meat sandwich) and then give 4 more blood samples at 10, 30, 60 and 120 minutes following the meal. The purpose of this control is to test whether ingestion of a recent meal might alter baseline blood purine measurements.
Main study patients recruited at University Hospitals North Midlands NHS Trust will also be given the option of participating in the Spasticity and Pharmacokinetic sub-studies. Participants taking part in the Spasticity sub-study will provide an additional blood sample to measure biomarkers and will undergo a spasticity assessment at admission, 24h, 72h, 7d and one or two clinic visits between 30-90d post-admission. Participants taking part in the pharmacokinetic sub-group will provide an additional blood sample for measurement of glutamate and other biomarkers at admission, 24h, 72h, 7d and 30-90d post-admission.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | –Adult stroke patients with suspected stroke will be recruited on admission to hospital. Recruitment will continue until 100 patients have received an MRI at 24h-72h post admission, up to a maximum recruitment threshold of 300 patients. |
| Control patients | – | –50 adult control patients will be recruited from the non-vascular, non-oncological surgical lists at each participating site |
| Feeding control participants | – | –15 healthy adult members of NHS staff will be recruited to participate in the feeding control sub-study at University Hospitals Coventry and Warwickshire NHS Trust only. |
| Spasticity sub-group controls | – | –10 healthy adult members of NHS staff at University Hospitals of North Midlands, will be recruited to take part as spasticity sub-study controls |
| Traumatic brain injury patients | – | –10 adult patients with an isolated traumatic brain injury at University Hospitals Coventry and Warwickshire NHS Trust and Imperial College Healthcare NHS Trust. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients: adult patients admitted to the hospital experiencing symptoms of stroke at the time of admission Controls: adult patients scheduled to undergo non-vascular, non-oncological surgery at the participating hospital sites Feeding control and spasticity sub-study control participants: Healthy adult members of NHS staff Traumatic brain injury sub-study: Adult patients with an isolated traumatic brain injury.
Key inclusion criteria (8 listed)
- Aged 18 years or over
- Admitted to hospital with suspected stroke, diagnosed by a suitably qualified doctor or nurse using an appropriate clinical assessment (e.g. FAST, NIHSS, WHO criteria)
- Patient has ongoing symptoms of stroke at the time of enrolment in to the study.
- Aged 18 years and over
- Scheduled for surgery
Key exclusion criteria (39 listed)
- Onset of stroke symptoms >4.5 hours prior to admission or time of onset of symptoms is not known
- Patient has undergone thrombolysis during current admission (N.B. patients can be enrolled before planned thrombolysis, but not after)
- Patient's stroke symptoms have resolved completely prior to enrolment in the study
- The patient, or their consultee if the patient is incapacitated, is unwilling to provide written informed consent
- Healthy controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether blood purine levels in stroke patients at admission correlate with infarct/ haemorrhage size as determined by MRI or CT scan at 24-72 hours after onset of symptoms
Time frame: 24-72h after onset of symptoms
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 12 Jul 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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 Imray, PhD principal investigator
University Hospitals Coventry and Warwickshire NHS Trust
1 site 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 1 site 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 8 inclusion and 39 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 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 determine whether blood purine levels in stroke patients at admission correlate with infarct/ haemorrhage size as determined by MRI or CT scan at 24-72 hours after onset of symptoms (time frame: 24-72h after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2022.