SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology

Conditions
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Stroke

Intervention / Treatment
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* Device: SMARTCap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected stroke patients and subset<br>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 | Device: SMARTCap<br>* 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.<br>|
| Control participants (relatives)<br>To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients | Device: SMARTCap<br>* 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.<br>|
| Feeding control participants<br>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 | Device: SMARTCap<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the levels of purine in the blood in Stroke patients compared to non-stroke patients (Healthy controls) |  | 30 minutes down to 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans |  | 24 hours to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMARTCap