Clinical validation of novel point-of-care hs-cTn assay in identifying patients with myocardial infarctio

• Conditions: acute coronary syndrome; chest pain; 10082206

• Registration Number: NL-OMON53273
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 308

Inclusion Criteria

- Age >= 18 years
- Symptoms suggestive of MI and troponin measurement for ruling out/in ACS is
indicated

Exclusion Criteria

- Age < 18 years
- Pregnancy
- No 12-lead ECG performed or available
- Electrocardiographic ST-segment elevation
- Missing measurements of the POC hs-cTnI or standard of care hs-cTn
- Patients transferred from an outside hospital (e.g. for PCI treatment)
- An obvious non-cardiac cause for the chest complaints (trauma, pneumothorax,
pneumonia, etc.)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. NSTE-ACS at discharge<br /><br>2. Myocardial infarction at discharge<br /><br>3. Safety endpoint: negative predictive value and sensitivity (POC hs-cTnI,<br /><br>standard of care hs-cTn)<br /><br>4. Accuracy endpoint: positive predictive value and specificity </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>5. Composite of all-cause mortality, MI and urgent revascularisation at 30 days<br /><br>6. Length of stay (in hours)<br /><br>7. Turnaround time POC and standard of care hsTroponin from blooddraw until<br /><br>result </p><br>