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Hollands-midden Acute Regional Triage - cardiology (HART-c): point-of-care high-sensitivity cardiac Troponin I study

Phase 3
Recruiting
Conditions
heart infarction
myocardial infarction
10011082
Registration Number
NL-OMON53852
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1672
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Phase 1 compares analytical performance of the POC device to conventional cTnT<br /><br>in the central laboratory. In phase 2 HEART scores will be compared between<br /><br>intervention and control.<br /><br><br /><br>The main study parameter in phase 3 is the percent change in number of patients<br /><br>left at home after ambulance nurse consultation. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are the occurrence of Major Adverse Cardiac Events (MACE),<br /><br>defined as death, ACS or percutaneous coronary intervention (PCI) 6 weeks after<br /><br>ED assessment. Furthermore (diagnostic) performance of POC device, sensitivity<br /><br>and specificity of the HEART - and HEAR (HEART score without Troponin<br /><br>measurement) score will be assessed. Furthermore a 'delta' POC hs-cTnI will be<br /><br>assessed which might lead tot faster time-to-diagnosis.</p><br>
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