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

Myocardial Infarction Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458155
• Other study ID #: Study number 580
• Secondary ID: METCZ20200008NL7
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: June 2022
• Source: VieCuri Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 1, 2021
• Est. primary completion date: December 19, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Ischemia
• Chest Pain
• Coronary Artery Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Siemens® Point-of-care high sensitive troponin I analyzer
Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.

Locations

Country	Name	City	State
Netherlands	Viecuri Medical Center	Venlo	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
VieCuri Medical Centre	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 vs. Siemens® POC venipuncture and vs. Siemens® POC plasma (Sample comparison).; The primary objective will be achieved by taking: Two capillary samples > one sample with a heparin coated transfer device (drawn from a finger of the right hand) and the other one with a non-heparin coated transfer device. (drawn from a finger of the left hand); One extra venous blood sample > for POC venous and POC plasma analysis.; Trained clinical staff will collect the different samples. All samples will be collected once, at one time point with a maximum of 10 minutes in between.	30 days
Secondary	Bland-Altman method	To compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the Bland-Altman method.	30 days
Secondary	Linear regression and Pearson's correlation.	The relationship between POC sample types by linear regression and Pearson's correlation.	30 days
Secondary	Overview baseline characteristics.	To create an overview of baseline characteristics of the population.	30 days
Secondary	Major adverse cardiac event (MACE)	MACE is is defined as a composite of cardiac death and myocardial infarction.	30 days
Secondary	Modified HEART score	To determine the modified HEART score retrospectively based upon POC capillary results in the population.	30 days
Secondary	Modified HEART score comparison	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.	30 days