SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke

Stroke Clinical Trial

— SMARTCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308605
• Other study ID #: CI126414 23 May 2014 V1
• Secondary ID: NIHR
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: April 19, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• SMARTCap
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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry
United Kingdom	University of Keele	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To measure the change in purines and their variability in control patients from baseline to day 7		24 hours - 7 days	No
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