heart infarction myocardial infarction
Conditions
Interventions
In phase 1 patients presenting to the ED or CEU will have POC hs-cTnI tested by
both CEU - or ED nurses and laboratory professionals. Analytical performances
of the POC device will be compared to la
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults (aged 18 years or older) presenting to the EMS with chest pain suspected to be of cardiac origin with good understanding of Dutch or English language and capable of giving informed consent.
Exclusion criteria
Exclusion criteria: Since the Siemens Healthineers Atellica VTLi is validated in chest pain experiencing chest pain for more than two hours, patients with chest pain since less than two hours will be excluded. Furthermore, the triage cardiologist is available on weekdays from 08.00-21.00. Patients presenting to the EMS paramedic outside of these hours are excluded from the study. Patients with ST-elevation on first ECG, non-cardiac chest pain (e.g. traumata, pneumonia, pneumothorax) or in cardiogenic shock/out-of-hospital cardiac arrest will be excluded. Furthermore if the ambulance nurse estimates that the time from inclusion and consultation will lead to worse patient outcomes they can choose to present patients directly to the ED or CEU. If patients are presented to another hospital then the three regional participating hospitals they will also be excluded. Patients in detention centers or asylum centers at the moment of triage will be excluded from the study since follow-up is not possible for these patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 compares analytical performance of the POC device to conventional cTnT in the central laboratory. In phase 2 HEART scores will be compared between intervention and control. The main study parameter in phase 3 is the percent change in number of patients left at home after ambulance nurse consultation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the occurrence of Major Adverse Cardiac Events (MACE), defined as death, ACS or percutaneous coronary intervention (PCI) 6 weeks after ED assessment. Furthermore (diagnostic) performance of POC device, sensitivity and specificity of the HEART - and HEAR (HEART score without Troponin measurement) score will be assessed. Furthermore a 'delta' POC hs-cTnI will be assessed which might lead tot faster time-to-diagnosis. | — |
Countries
Netherlands
Outcome results
None listed