SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke (SMARTCAP)

University Hospitals Coventry and Warwickshire NHS Trust

Status: Completed

Conditions: Stroke

Treatments: Device: SMARTCap

Study type: Observational

Funder types: Other

Identifiers

NCT02308605

CI126414 23 May 2014 V1

NIHR (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 217 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

217 participants in 3 patient groups

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

Treatment:

Device: SMARTCap

Control participants (relatives)

Description:

To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients

Treatment:

Device: SMARTCap

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

Treatment:

Device: SMARTCap