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

NCT04458155 | Completed DMC

• 3 other identifiers: Study number 580METCZ20200008NL72445.096.20
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Troponin; Point-of-care; Acute coronary syndrome; Siemens; Chest pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Bland-Altman method

  30 days

• Linear regression and Pearson's correlation.

  30 days

• Overview baseline characteristics.

  30 days

• Major adverse cardiac event (MACE)

  30 days

• Modified HEART score

  30 days

Study Arms (1)

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

Interventions

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

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

Chest pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 years or older.
• Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VieCuri Medical Centre: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Viecuri Medical Center

Venlo, Limburg, 5912 BL, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Capillary blood, venous blood and blood plasma

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Braim Rahel, Dr.

  VieCuri Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. B.M. Rahel, Principal investigator, Cardiologist

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: June 18, 2020
• Primary Completion: December 19, 2020
• Study Completion: April 1, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

NL (1)