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
Henk.peels@philips.com
Trial website
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 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
01/12/2014
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
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
Funders
Funder type
Government
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
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