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

Clinical validation of novel point-of-care hs-cTn assay in identifying patients with myocardial infarction - POPULAR CONCORDANT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53273

Enrollment

308

Registered

2023-11-09

Start date

2024-01-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome chest pain

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Secondary

Measure	Time frame
5. Composite of all-cause mortality, MI and urgent revascularisation at 30 days 6. Length of stay (in hours) 7. Turnaround time POC and standard of care hsTroponin from blooddraw until result	—

Primary

Measure	Time frame
1. NSTE-ACS at discharge 2. Myocardial infarction at discharge 3. Safety endpoint: negative predictive value and sensitivity (POC hs-cTnI, standard of care hs-cTn) 4. Accuracy endpoint: positive predictive value and specificity	—

Countries

Netherlands

Outcome results