SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke

Completed

• Conditions: Stroke
• Interventions: Device: SMARTCap

• Registration Number: NCT02308605
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected stroke patients and subset	SMARTCap	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
Control participants (relatives)	SMARTCap	To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients
Feeding control participants	SMARTCap	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans	24 hours to 7 days

Trial Locations

Locations (2)

University of Keele; 🇬🇧 Stoke-on-Trent, United Kingdom

University Hospitals Coventry & Warwickshire NHS Trust; 🇬🇧 Coventry, United Kingdom