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Sample comparison with Siemens® point-of-care device for cardiac troponin I assay by using a heparin coated transfer device vs. non-heparin coated transfer device at the emergency department (validation study 2.0).

Sample comparison with Siemens® point-of-care device for cardiac troponin I assay by using a heparin coated transfer device vs. non-heparin coated transfer device at the emergency department (validation study 2.0). - Li-Hep vs. non-Li-Hep coated transfer device for POC HS cTnI.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49115
Enrollment
130
Registered
2020-02-12
Start date
2020-06-18
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

acute coronary syndrome heart attack

Interventions

None listed

Sponsors

Viecuri Medisch Centrum voor Noord-Limburg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age 18 years or older. * Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T

Exclusion criteria

Exclusion criteria: * Out of hospital cardiac arrest. * Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular) * Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc. * Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site. * Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.

Design outcomes

Primary

MeasureTime frame
Sample comparison: The primary objective is to compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the coefficient of variation. This comparison will comprise Siemens® POC capillary (2 fingersticks: one sample with a heparin coated transfer device and one sample with a non-heparin coated transfer device) vs. Siemens® POC venipuncture and vs. Siemens® POC plasma.—

Secondary

MeasureTime frame
* The relationship between POC sample types by the Bland-Altman method. * The relationship between POC sample types by linear regression and Pearson*s correlation. * To create an overview of baseline characteristics of the population. * The mortality and major adverse cardiovascular events (MACE) of the population at 30 days. MACE is defined as a composite of cardiac death and myocardial infarction. * To determine the modified HEART score retrospectively based upon POC capillary results in the population. * To compare the retrospectively determined modified HEART score based upon POC capillary heparin coated transfer device with the retrospectively determined modified HEART score based upon POC capillary non-heparin coated transfer device.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)