Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively 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, or 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 Philips Minicare cTn-I test used on the handheld Minicare I-20 instrument, is an In vitro diagnostic test for measuring cardiac troponin I (cTnI) in blood samples designed to be used at the point-of-care (POC) by healthcare professionals as well as in the clinical laboratory. The European Performance Evaluation Study of Minicare cTn-I system is a performance evaluation designed to test whether the Minicare cTn-I is suitable for the measurement of cTn-I as to help diagnose acute MI (AMI) for patients presenting at the emergency department (ED) with suspicion of an acute heart condition. Based on the results of this study, the device will be placed on the EU market/ put into service in accordance with all applicable laws and regulations. The primary objective of the study is to test the performance of the Minicare cTn-I test on the Philips Minicare I-20 device. Clinical performance evaluation will be based on clinical sensitivity and specificity for the diagnosis of AMI of the Minicare cTn-I test in Li-heparin whole blood and in Li-heparin plasma samples. This study involves evaluating the final product developed as described in

Who can participate?
Adults (at least 18 years old) with symptoms suggestive of a AMI.

What does the study involve?
Participants have blood samples taken on arrival to hospital, then 2-4 hours later and then 6-24 hours later if they are still in the hospital by this time.

What are the possible benefits and risks of participating?
There is no direct individual benefit for participants, other than helping developing a faster method to determine blood levels of troponin which enables a faster diagnosis of a possible myocardial infarction. This is important because a faster diagnosis will lead to quicker treatment and ultimately reduced damage to the heart tissue. There are no anticipated risks for the subjects participating in the performance evaluation. A blood sample will be used as normally used in a routine hospital setting. Further the study is observational, so no diagnosis will be done with our device. Diagnosis of the subjects will remain to be based on the hospital standard of care.

Where is the study run from?
Hospitals in the EU – France, Germany, Netherlands and the United Kingdom.

When is the study starting and how long is it expected to run for?
November 2014 to December 2015

Who is funding the study?
Philips Electronics Nederland B.V., Handheld Diagnostics (Netherlands)

Who is the main contact?
Mr Diederick Keizer

Trial website

Contact information



Primary contact

Mr. Diederick Keizer


Contact details

High Tech Campus 29
Building HTC29.p.519

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

European performance evaluation study for the Philips Minicare cTn-I system: an observational study


Study hypothesis

To evaluate the clinical performance of the Minicare cTn-I test on the Philips Minicare I-20 device. Clinical performance evaluation will be based on clinical sensitivity and specificity for the diagnosis of AMI of the Minicare cTn-I test in Li-heparin whole blood and in Li-heparin plasma samples.

This study involves evaluating the final product developed as described in

Ethics approval

Ethics submission to the West Midlands – Solihull REC.

Study design

The study will be a European multi-center, prospective, non-randomized design, in an open, surveillance study with about 550 patients enrolled suspected of ACS. Enrollment will be stopped after positive adjudication of 50 patients with confirmed AMI, including the 6-24 blood sample.

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.


Measuring cardiac cTn-I at the patient's bedside as an aid in the diagnosis of myocardial infarction (MI)


Patients will have blood samples drawn in the ER (or CCU) at three different time points: when possible t=0 at presentation at ED of the hospital (defined as baseline sample), followed at 2 – 4 hours, and at 6 – 24 hours after first blood sample if the patient is still in the hospital at these time points.

Intervention type



Drug names

Primary outcome measures

From each enrolled patient, Li-heparin plasma and Li-heparin whole blood samples will be analyzed using the Minicare cTn-I System. In parallel, Li-heparin plasma sample will be tested using the hospital standard cTn assay (Elecsys Troponin T high sensitive Roche). Leftover of Li-heparin plasma will be stored for further analysis (aliquots at -80°C).

The final diagnosis of AMI will be based on adjudication by an external board of cardiologists. Only patients with at least one cTn result above the 99th perc. URL using the hospital standard cTn method will be adjudicated. All other patients will be assumed non-MI.

Secondary outcome measures

1. To estimate the positive and negative predictive value of the Minicare cTn-I System
2. To evaluate the overall agreement between the Minicare cTn-I Test System and the hospital standard cTn assay
3. To evaluate agreement between Li-heparin plasma and Li-heparin whole blood

Primary and secondary outcomes are related to the same data collection set and will be evaluated after close of the study and during data analysis.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

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

Participant type


Age group




Target number of participants


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 not willing or not able to provide informed consent due to their medical condition as judged by the physician

Recruitment start date


Recruitment end date



Countries of recruitment

France, Germany, Netherlands, United Kingdom

Trial participating centre

Department of Emergency and Intensive Care, Nuremberg Hospital (Klinik für Notfall- und Internistische Intensivmedizin; Klinikum Nürnberg)
Prof. Ernst-Nathan-Str. 1

Trial participating centre

Pitié-Salpêtrière Hospital (CHU Pitié-Salpêtrière)
47-83 Boulevard de l'Hôpital

Trial participating centre

University of Sheffield
Western Bank
S10 2TN
United Kingdom

Trial participating centre

University Medical Center Goettingen
Robert-Koch-Straße 40

Trial participating centre

University Hospital Heidelberg (Uniklinik Heidelberg)
Im Neuenheimer Feld 672

Trial participating centre

Henri Mondor Hospital
51 Avenue du Maréchal de Lattre de Tassigny

Trial participating centre

St. Antonius Hospital (St. Antonius Ziekenhuis)
Postbus 2500 Nieuwegein
3430 EM

Sponsor information


Philips Electronics Nederland B.V., Handheld Diagnostics

Sponsor details

High Tech Campus 29

Sponsor type




Funder type


Funder name

Philips Electronics Nederland B.V., Handheld Diagnostics (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes