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Trial record 1 of 1 for:    SMARTCAP
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SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke (SMARTCAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Christopher Imray, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier:
NCT02308605
First received: October 3, 2014
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention
Stroke
Device: SMARTCap

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology

Further study details as provided by University Hospitals Coventry and Warwickshire NHS Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans [ Time Frame: 24 hours to 7 days ]

Other Outcome Measures:
  • To measure the change in purines and their variability in control patients from baseline to day 7 [ Time Frame: 24 hours - 7 days ]

Enrollment: 217
Study Start Date: September 2014
Study Completion Date: December 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Suspected stroke patients and subset

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

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.
Control participants (relatives)
To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients
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.
Feeding control participants
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
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.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
320
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02308605

Locations
United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom, CV2 2DX
University of Keele
Stoke-on-Trent, United Kingdom, ST4 7QB
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
Principal Investigator: Christopher HE Imray, MB BS FRCP PhD University Hospitals Coventry & Warwickshire NHS Trust
  More Information

Responsible Party: Professor Christopher Imray, Professor Christopher Imray, Consultant Vascular Surgeon, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT02308605     History of Changes
Other Study ID Numbers: CI126414 23 May 2014 V1
NIHR ( Other Grant/Funding Number: ll-LA-0313-20002 )
Study First Received: October 3, 2014
Last Updated: April 19, 2016

Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
SMARTCap

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 27, 2017