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

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ClinicalTrials.gov Identifier: NCT04458155
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Siemens Corporation, Corporate Technology
Information provided by (Responsible Party):
Braim Rahel, VieCuri Medical Centre

Brief Summary:
This study is a prospective, diagnostic, cohort study within the standard care of ACS patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. We 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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Chest Pain Myocardial Infarction Cardiac Ischemia Device: Siemens® Point-of-care high sensitibe 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. We 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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
Chest pain patients

Patients are eligble for participation if they are admitted to:

  • The cardiac ED because of chest pain for rulling out acute coronary syndrome by troponin analysis
  • The Coronary Care Unit (CCU) with a NSTEMI or post-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 regulary ordered blood work to evaluate HS cTnI levels obtained with the POC instrument.

Device: Siemens® Point-of-care high sensitibe 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.




Primary Outcome Measures :
  1. Sample comparison [ Time Frame: 30 days ]

    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.



Secondary Outcome Measures :
  1. Bland-Altman method [ Time Frame: 30 days ]
    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.

  2. Linear regression and Pearson's correlation. [ Time Frame: 30 days ]
    The relationship between POC sample types by linear regression and Pearson's correlation.

  3. Overview baseline characteristics. [ Time Frame: 30 days ]
    To create an overview of baseline characteristics of the population.

  4. Major adverse cardiac event (MACE) [ Time Frame: 30 days ]
    MACE is is defined as a composite of cardiac death and myocardial infarction.

  5. Modified HEART score [ Time Frame: 30 days ]
    To determine the modified HEART score retrospectively based upon POC capillary results in the population.

  6. Modified HEART score comparison [ Time Frame: 30 days ]
    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.


Biospecimen Retention:   Samples With DNA
Capillary blood, venous blood and blood plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458155


Contacts
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Contact: Lisa Frenk, Drs. +31773205555 lfrenk@viecuri.nl
Contact: Anne Bruinen, Dr. +31773205555 abruinen@viecuri.nl

Locations
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Netherlands
Viecuri Medical Center Recruiting
Venlo, Limburg, Netherlands, 5912 BL
Contact: Lisa Frenk, Drs.    077 320 5555    lfrenk@viecuri.nl   
Contact: Anne Bruinen, Drs.    077 320 5555    abruinen@viecuri.nl   
Sub-Investigator: Lisa Frenk, Drs.         
Sub-Investigator: Anne Bruinen, Dr.         
Principal Investigator: Braim Rahel, Dr.         
Sponsors and Collaborators
VieCuri Medical Centre
Siemens Corporation, Corporate Technology
Investigators
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Principal Investigator: Braim Rahel, Dr. VieCuri Medical Centre
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Responsible Party: Braim Rahel, Dr. B.M. Rahel, VieCuri Medical Centre
ClinicalTrials.gov Identifier: NCT04458155    
Other Study ID Numbers: Study number 580
METCZ20200008 ( Other Identifier: Medical ethical committee )
NL72445.096.20 ( Other Identifier: ToetsingOnline ID/CCMO ID )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Braim Rahel, VieCuri Medical Centre:
Troponin
Point-of-care
Acute coronary syndrome
Siemens
Chest pain
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Chest Pain
Pathologic Processes
Necrosis
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis