Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
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) 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 this 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

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

Trial website

Contact information



Primary contact

Mr Henk Peels


Contact details

High Tech Campus
+31 (0)653559459

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



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


Secondary study design

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

Trial setting


Trial type


Patient information sheet

Available on website


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


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



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

Austria, France, Germany, Netherlands, United Kingdom

Trial participating centre

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

Trial participating centre

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

Trial participating centre

Stichting Catharina Ziekenhuis

Trial participating centre

Klinik für Notfall- und Internistische Intensivmedizin

Trial participating centre

Universitätsklinik für Innere Medizin III Klinisches Studienzentrum Kardiologie & Angiologie

Trial participating centre

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

Sponsor information


Philips Electronics Nederland, B.V. - HandHeld Diagnostics

Sponsor details

High Tech Campus 29
5656 AE

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

No publications are envisaged related to this study.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/11/2017: Publication and dissemination plan updated.