Performance testing of the Minicare cTnI system in the Emergency Department
| ISRCTN | ISRCTN99484822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99484822 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/12/2014
- Registration date
- 02/01/2015
- Last edited
- 13/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
High Tech Campus
HTC29P2.69
Eindhoven
5656AE
Netherlands
| Phone | +31 (0)653559459 |
|---|---|
| henk.peels@philips.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Available on website |
| Scientific title | Demonstrating Minicare, a miniaturized biophotonics platform for fast and lab-equivalent Point-of-Care diagnostics |
| Study acronym | Lab2Go |
| Study objectives | 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(s) | Proportionate Review Sub-committee of the NRES Committee South East Coast - Surrey. Ref: 14/LO/2012 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/12/2014 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2014 |
| Date of final enrolment | 01/06/2016 |
Locations
Countries of recruitment
- Austria
- England
- France
- Germany
- Netherlands
- United Kingdom
Study participating centres
SW17 0QT
United Kingdom
S10 2JF
United Kingdom
-
Netherlands
-
Germany
-
Austria
-
France
Sponsor information
Industry
High Tech Campus 29
Eindhoven
5656 AE
Netherlands
| Phone | +31(0)610212150 |
|---|---|
| jos.rijntjes@philips.com | |
| Website | www.philips.com/minicare |
"ROR" |
https://ror.org/02p2bgp27 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | No publications are envisaged related to this study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/11/2017: Publication and dissemination plan updated.
