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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02308605
Acronym
SMARTCAP
Enrollment
217
Registered
2014-12-04
Start date
2014-09-30
Completion date
2015-12-31
Last updated
2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

SMARTCap

Brief 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.

Interventions

DEVICESMARTCap

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.

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. 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 2. Control participants: Relatives of patients admitted to the stroke treatment pathway, who are healthy and have no signs of cardiovascular illness 3. Healthy volunteers

Exclusion criteria

1. Stroke patients: Delay in admission exceeds the time window of 4 hours between stroke symptoms and admission 2. Control participants: Obvious signs or history of cerebrovascular disease 3. Unhealthy volunteers

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans24 hours to 7 days

Other

MeasureTime frame
To measure the change in purines and their variability in control patients from baseline to day 724 hours - 7 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026