Acute coronary syndrome
Conditions
Interventions
HEART score on the ED and CEU with labo
Phase 1:
In Phase 1, the analytical performance of the POC hs-cTnI test will be validated, especially at the low concentration end of cTnI, according to its intended use. In addition, non-inferiority
Sponsors
Department of Cardiology, Leiden University Medical Center
Eligibility
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: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameter for phase 1 is the evaluation of operator variability by comparing ED - and clinical chemical lab results on the POC hs cTnI device. Secondary study parameters for phase 2 are HEART scores using POC device, ‘standard care’ HEART scores and sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) respectively. Furthermore MACE (death, ACS or PCI 30 days after assessment) rates will be assessed. Secondary study parameters for phase 3 are HEART- and HEAR scores by ambulance nurses (and sensitivity, specificity, NPV, PPV respectively), MACE rates, (diagnostic) performance of POC device in the ambulance, time from ambulance nurse assessment to hospital, interhospital transfers after ED – or CEU assessment, final diagnoses (also for patients left at home), re-admission rates. | — |
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Assessment of analytical performance specifications of POC hs-cTnI device as compared to the manufacturer’s claims. Benchmark of POC analytical performance compared to the “gold” standard, i.e. conventional central lab hs cTnT test. Phase 2: Clinical comparability in HEART score of POC hs cTnI and standard clinical care Phase 3: Increase in number of chest pain patients left at home. Defined as the fraction of chest pain patients left at home in relation to all chest pain patients included | — |
Contacts
Public ContactEnrico de Koning
Leiden Universitair Medical Center
Outcome results
None listed