European performance evaluation study for the Philips Minicare cTn-I system
Not Applicable
Completed
- Conditions
- Measuring cardiac cTn-I at the patient's bedside as an aid in the diagnosis of myocardial infarction (MI)Circulatory System
- Registration Number
- ISRCTN77371338
- Lead Sponsor
- Philips Electronics Nederland B.V., Handheld Diagnostics
- Brief Summary
2018 Results article in https://doi.org/10.1515/cclm-2017-0693 (added 08/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 550
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 21/09/2017:<br> Sensitivity and specificity of Minicare cTnI in Li-Hep whole blood and Li-Hep plasma, calculated using the 99th percentile URL value of 43 ng/L, measured at 0h, 2-4h and 6-24h after presentation<br><br> Previous primary outcome measures:<br> 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).<br><br> 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.<br>
- Secondary Outcome Measures
Name Time Method <br> Current secondary outcome measures as of 21/09/2017:<br> The positive and negative predictive value of Minicare cTnI in Li-Hep whole blood and Li-Hep plasma, calculated using the 99th percentile URL value of 43 ng/L, measured at 0h, 2-4h and 6-24h after presentation<br><br> Previous secondary outcome measures:<br> 1. To estimate the positive and negative predictive value of the Minicare cTn-I System<br> 2. To evaluate the overall agreement between the Minicare cTn-I Test System and the hospital standard cTn assay<br> 3. To evaluate agreement between Li-heparin plasma and Li-heparin whole blood<br><br> 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.<br>