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NCT Number: NCT02308605

SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Coventry & Warwickshire NHS Trust, Coventry, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMARTCap

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans

    Time frame: 24 hours to 7 days

Other outcomes

  1. To measure the change in purines and their variability in control patients from baseline to day 7

    Time frame: 24 hours - 7 days

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

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

Acronym: SMARTCAP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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