Performance testing of the Minicare cTnI system in the Emergency Department
Completed
- Conditions
- Measuring cardiac cTnI at the patient’s bedside as an aid in the diagnosis of myocardial infarction (MI)Circulatory SystemMyocardial infarction (MI)
- Registration Number
- ISRCTN99484822
- Lead Sponsor
- Philips Electronics Nederland, B.V. - HandHeld Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 700
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method sers (nurses) will be observed and interviewed to gather user feedback on the use of the system.<br>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.