NCT02308605

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

October 3, 2014

Last Update Submit

April 19, 2016

Conditions

Stroke

Keywords

SMARTCap

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans

    24 hours to 7 days

Other Outcomes (1)

  • To measure the change in purines and their variability in control patients from baseline to day 7

    24 hours - 7 days

Study Arms (3)

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

Control participants (relatives)

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

Device: SMARTCap

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

Interventions

SMARTCapDEVICE

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)Feeding control participantsSuspected stroke patients and subset

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

320

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

University of Keele

Stoke-on-Trent, ST4 7QB, United Kingdom

Location

Related Publications (1)

  • Dale N, Tian F, Sagoo R, Phillips N, Imray C, Roffe C. Point-of-care measurements reveal release of purines into venous blood of stroke patients. Purinergic Signal. 2019 Jun;15(2):237-246. doi: 10.1007/s11302-019-09647-4. Epub 2019 Mar 12.

    PMID: 30859371DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christopher HE Imray, MB BS FRCP PhD

    University Hospitals Coventry & Warwickshire NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Christopher Imray, Consultant Vascular Surgeon

Study Record Dates

First Submitted

October 3, 2014

First Posted

December 4, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

GB(2)