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

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)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Chest Pain; Acute Coronary Syndrome; Cardiac Ischemia
• Intervention / Treatment: Device: Siemens® Point-of-care high sensitive troponin I analyzer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Venlo, Limburg, Netherlands, 5912 BL
      • VieCuri Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients presented at our cardiology ED or coronary care unit (CCU) are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, ECG and regular troponin results from the central laboratory.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Chest pain patients; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac event (MACE)	MACE is is defined as a composite of cardiac death and myocardial infarction.	30 days
Overview baseline characteristics.	To create an overview of baseline characteristics of the population.	30 days
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
Linear regression and Pearson's correlation.	The relationship between POC sample types by linear regression and Pearson's correlation.	30 days
Modified HEART score	To determine the modified HEART score retrospectively based upon POC capillary results in the population.	30 days
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

Collaborators and Investigators

• Sponsor: VieCuri Medical Centre
• Collaborators: Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Braim Rahel, Dr., Viecuri Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): December 19, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Chest pain; Point-of-care; Troponin; Siemens
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: Study number 580; METCZ20200008 (Other Identifier: Medical ethical committee); NL72445.096.20 (Other Identifier: ToetsingOnline ID/CCMO ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No