Condition category
Circulatory System
Date applied
10/12/2014
Date assigned
02/01/2015
Last edited
13/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Heart disease is the largest single cause of death throughout the European Union. Many patients with heart attacks (myocardial infarction MI) come to hospital with chest pain. In order to determine if this chest pain is due to a heart attack or is due to some other cause such as a chest infection or muscular pain, tests are performed. The two most important types of tests are the electrocardiogram (ECG) and blood tests to see if there is any evidence of heart damage. The test which is now used to detect heart damage in the blood is the measurement of a molecule called cardiac cTnI. The Lab 2 Go project is a European Union funded Research and Development project involving hospitals in the European Union. The aim of the study is to determine the value of a method of measuring cardiac cTnI at the patient’s bedside (point of care testing). Point-of-care cTnI testing has the potential to accelerate diagnosis and improve patient care. A blood sample can be taken and tested by the doctor, nurse or paramedic to provide cTnI measurement during clinical assessment, rather than having to wait for laboratory results. The study aims to assess the analytical and clinical performance compared to available lab based reference systems.

Who can participate?
Adults coming to hospitals with chest pains and who accept to take part.

What does the study involve?
Blood samples tested using the point of care device under assessment.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
hospitals in the EU – Austria, France, Germany, Netherlands (UK)

When is the study starting and how long is it expected to run for?
December 2014 to June 2016

Who is funding the study?
European Union

Who is the main contact?
Mr Henk Peels
Henk.peels@philips.com

Trial website

http://www.lab2go.eu/

Contact information

Type

Public

Primary contact

Mr Henk Peels

ORCID ID

Contact details

High Tech Campus
HTC29P2.69
Eindhoven
5656AE
Netherlands
+31(0)653559459
henk.peels@philips.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Demonstrating Minicare, a miniaturized biophotonics platform for fast and lab-equivalent Point-of-Care diagnostics.

Acronym

Lab2Go

Study hypothesis

The goal of the Lab2Go project is to bring a (handheld) Point-of-Care test-device to the next level of maturity by demonstrating it in real user environments.

Ethics approval

Proportionate Review Sub-committee of the NRES Committee South East Coast - Surrey. Ref: 14/LO/2012

Study design

The Lab 2 Go project is a European Union funded multicentre Research and Development project (project nr. 621035) involving 6 hospitals in the European Union.
The project is a study on suspected MI patients to determine the value of a method of measuring cardiac cTnI at the patient’s bedside (point of care testing). The study aims to assess the analytical and clinical performance compared to available lab based reference systems.

Primary study design

Observational

Secondary study design

Gather user feedback on the usability of the system in the ED.

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Available on website

Condition

Measuring cardiac cTnI at the patient’s bedside as an aid in the diagnosis of Myocardial infarction (MI)

Intervention

Patient blood will be tested on the POC device and the result compared to local Troponin Lab test results. The study does not interfere with routine patient treatment and does not alter the routine diagnosis of the patients condition.

Intervention type

Device

Phase

Drug names

Primary outcome measures

For individual patients, blood samples will be tested on the POC device from up to three time points (t=0, t=2-4 hours and t = 6-24 hours). Each result is a quantitative TnI measurement which can be compared to results generated by the local Lab equipment.

Secondary outcome measures

Users (nurses) will be observed and interviewed to gather user feedback on the use of the system.
Data regarding the hospital workflow for MI patients will be gathered to allow determining whether workflow efficiency can potentially be improved with the introduction of POC testing.

Overall trial start date

01/12/2014

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. ≥ 18 years old
2. Patients presenting with symptoms suggestive of ACS, at ER or CCU
3. Patients presenting for the 1st time after onset of symptoms
4. Onset of last episode of symptoms suggestive of AMI <12 hrs prior to presentation
5. Signed informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

In total for all participating hospitals 300-350 patients for analytical performance testing and 600-700 patients for clinical performance testing.

Participant exclusion criteria

1. Patients already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site
2. Patients requiring emergency treatment (respiratory or cardiovascular support, arrhythmia control, coronary reperfusion)
3. Cognitive impairment or inability to understand study information
4. Unwilling or unable to provide written consent

Recruitment start date

01/12/2014

Recruitment end date

01/06/2016

Locations

Countries of recruitment

Austria, France, Germany, Netherlands, United Kingdom

Trial participating centre

St George’s Healthcare NHS Trust
London
SW17 0QT
United Kingdom

Trial participating centre

National Institute for Health Research Sheffield, Clinical Research Facility
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Stichting Catharina Ziekenhuis
Eindhoven
Netherlands

Trial participating centre

Klinik für Notfall- und Internistische Intensivmedizin
Nurnberg
Germany

Trial participating centre

Universitätsklinik für Innere Medizin III Klinisches Studienzentrum Kardiologie & Angiologie
Innsbruck
Austria

Trial participating centre

CHU Pitié-Salpêtrière AP-HP et Université Pierre et Marie Curie
Paris
France

Sponsor information

Organisation

Philips Electronics Nederland, B.V. - HandHeld Diagnostics

Sponsor details

High Tech Campus 29
Eindhoven
5656 AE
Netherlands
+31(0)610212150
jos.rijntjes@philips.com

Sponsor type

Industry

Website

www.philips.com/minicare

Funders

Funder type

Industry

Funder name

European Union funded multicentre Research and Development project (project nr. 621035)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results are reported within the Lab2Go gant organisation (consortium) and will be published in peer-reviewed journals.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes