NCT02308605

SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	SMARTCap	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2014-12-04
• Last updated: 2016-04-20

Locations

2 sites across 1 country: United Kingdom