Skip to content

Performance testing of the Minicare cTnI system in the Emergency Department

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN99484822
Enrollment
700
Registered
2015-01-02
Start date
2014-12-01
Completion date
Unknown
Last updated
2017-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 di

Sponsors

Philips Electronics Nederland, B.V. - HandHeld Diagnostics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Austria, France, Germany, Netherlands, United Kingdom

Contacts

Public ContactHenk Peels
henk.peels@philips.com+31 (0)653559459

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026