Li-Hep vs. Non-Li-Hep Coated Transfer Device

VieCuri Medical Centre

Status: Completed

Conditions: Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Cardiac Ischemia

Treatments: Device: Siemens® Point-of-care high sensitive troponin I analyzer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04458155

NL72445.096.20 (Other Identifier)

METCZ20200008 (Other Identifier)

Study number 580

Details and patient eligibility

About

This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from ~10% to ≤ 5% when using heparinized transfer device for the capillary sample.

Full description

In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient.

The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of >0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types.

It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older.
• Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or one hour after arrival (T=1).
• Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI.
• STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI.

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.

Trial design

70 participants in 1 patient group

Chest pain patients

Description:

Patients are eligible for participation if they are admitted to: * The cardiac emergency department (ED) because of chest pain for ruling out acute coronary syndrome by troponin analysis * The Coronary Care Unit (CCU) with a NSTEMI or post-percutaneous coronary intervention (PCI) STEMI. Troponin analysis will be performed according to standard protocol. From every included patient two capillary blood samples and an extra venous blood sample will be drawn during regularly ordered blood work to evaluate HS cTnI levels obtained with the POC instrument.

Treatment:

Device: Siemens® Point-of-care high sensitive troponin I analyzer