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

NCT ID: NCT04458155

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2021-04-01

Brief 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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role: collaborator

VieCuri Medical Centre

OTHER

Sponsor Role: lead

Responsible Party

Braim Rahel

Dr. B.M. Rahel, Principal investigator, Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Braim Rahel, Dr.

Role: PRINCIPAL_INVESTIGATOR

VieCuri Medical Centre

Locations

Viecuri Medical Center

Venlo, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

METCZ20200008

Identifier Type: OTHER

Identifier Source: secondary_id

NL72445.096.20

Identifier Type: OTHER

Identifier Source: secondary_id

Study number 580

Identifier Type: -

Identifier Source: org_study_id