H232: Analytical Validation of the Roche Cardiac Reader

H232: Analytical Validation of the Roche Cardiac Reader - Cardiac Reader Validation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43458

Enrollment

100

Registered

2016-04-14

Start date

2016-08-18

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

heart attack Myocard infarction

Interventions

Drawing additional blood sample from existing vena puncture

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults for whom a venapuncture is performed for analyses of D-dimer, NT-proBNP and/or Troponin T

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Main endpoint is the comparison with the reference method, and reproducibility of measurements. For statistical criteria, see the corresponding section.	—

Secondary

Measure	Time frame
We will document the time needed to generate a result (pre-analyses as well as measurement time) using the H232. Also, user friendliness will be assessed.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)