SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke "SMARTCAP"

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • SMARTCap Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Suspected stroke patients and subset
    Description: 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
    ARM 2: Kind: Experimental
    Label: Control participants (relatives)
    Description: To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients
    ARM 3: Kind: Experimental
    Label: Feeding control participants
    Description: 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

Trial Design

  • Observation: Case Control
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

320

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans 24 hours to 7 days No

Sponsors