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

Not yet recruiting
Conditions
Acute coronary syndrome
Registration Number
NL-OMON28373
Lead Sponsor
Department of Cardiology, Leiden University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
600
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Phase 1:<br>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.<br>Phase 2:<br>Clinical comparability in HEART score of POC hs cTnI and standard clinical care<br>Phase 3:<br>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
Secondary Outcome Measures
NameTimeMethod
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.<br><br>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. <br><br>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.
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