<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458155</url>
  </required_header>
  <id_info>
    <org_study_id>Study number 580</org_study_id>
    <secondary_id>METCZ20200008</secondary_id>
    <secondary_id>NL72445.096.20</secondary_id>
    <nct_id>NCT04458155</nct_id>
  </id_info>
  <brief_title>Li-Hep vs. Non-Li-Hep Coated Transfer Device</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VieCuri Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Siemens Corporation, Corporate Technology</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>VieCuri Medical Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, diagnostic, cohort study within the standard care of acute&#xD;
      coronary syndrome (ACS) patients. It compares the analytical performance of Siemens®&#xD;
      point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types.&#xD;
      The investigators hypothesize that there is a good correlation between the Siemens® POC HS&#xD;
      cTnI assay results for the three sample types and that the bias between different POC sample&#xD;
      types reduces from ~10% to ≤ 5% when using heparinized transfer device for the capillary&#xD;
      sample.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens&#xD;
      POC device on three sample types are compared. Interim analysis of the sample comparison was&#xD;
      performed by regression analysis using Passing and Bablock, and calculating the Pearson&#xD;
      correlation coefficient.&#xD;
&#xD;
      The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R&#xD;
      of &gt;0.99, so the results between these sample types can be used interchangeably. For the&#xD;
      capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With&#xD;
      a 8-12% higher response, the capillary test results may not be interchangeably used with the&#xD;
      other 2 sample types.&#xD;
&#xD;
      It is remarkable that capillary samples give a higher response, since it was anticipated that&#xD;
      the result may be slightly lower due to the possible dilution by interstitial fluid. The&#xD;
      investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous&#xD;
      draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated&#xD;
      transfer device for the capillary samples instead of an uncoated transfer device, this&#xD;
      hypothesis will be tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sample comparison</measure>
    <time_frame>30 days</time_frame>
    <description>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.&#xD;
This comparison will comprise Siemens® POC capillary vs. Siemens® POC venipuncture and vs. Siemens® POC plasma (Sample comparison).&#xD;
The primary objective will be achieved by taking:&#xD;
Two capillary samples &gt; 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)&#xD;
One extra venous blood sample &gt; for POC venous and POC plasma analysis.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bland-Altman method</measure>
    <time_frame>30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear regression and Pearson's correlation.</measure>
    <time_frame>30 days</time_frame>
    <description>The relationship between POC sample types by linear regression and Pearson's correlation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overview baseline characteristics.</measure>
    <time_frame>30 days</time_frame>
    <description>To create an overview of baseline characteristics of the population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac event (MACE)</measure>
    <time_frame>30 days</time_frame>
    <description>MACE is is defined as a composite of cardiac death and myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified HEART score</measure>
    <time_frame>30 days</time_frame>
    <description>To determine the modified HEART score retrospectively based upon POC capillary results in the population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified HEART score comparison</measure>
    <time_frame>30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Chest Pain</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Cardiac Ischemia</condition>
  <arm_group>
    <arm_group_label>Chest pain patients</arm_group_label>
    <description>Patients are eligible for participation if they are admitted to:&#xD;
The cardiac emergency department (ED) because of chest pain for ruling out acute coronary syndrome by troponin analysis&#xD;
The Coronary Care Unit (CCU) with a NSTEMI or post-percutaneous coronary intervention (PCI) STEMI.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Siemens® Point-of-care high sensitive troponin I analyzer</intervention_name>
    <description>Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.</description>
    <arm_group_label>Chest pain patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Capillary blood, venous blood and blood plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presented at our cardiology ED or coronary care unit (CCU) are eligible for&#xD;
        inclusion if they are 18 years or older and suspected of having an ACS based on history,&#xD;
        examination, ECG and regular troponin results from the central laboratory.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or&#xD;
             one hour after arrival (T=1).&#xD;
&#xD;
          -  Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for&#xD;
             coronary angiography but do not need rescue/emergency PCI.&#xD;
&#xD;
          -  STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Out of hospital cardiac arrest.&#xD;
&#xD;
          -  Patients with sudden onset tachycardia and a frequency of 110 bpm or higher&#xD;
             (supraventricular or ventricular).&#xD;
&#xD;
          -  Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis&#xD;
             is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.&#xD;
&#xD;
          -  Patients recently already admitted for the same set of symptoms at a previous&#xD;
             healthcare institution before being transferred to the participating clinical site.&#xD;
&#xD;
          -  Patients not willing or not able to provide informed consent due to their medical&#xD;
             condition as judged by the physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Braim Rahel, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>VieCuri Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Viecuri Medical Center</name>
      <address>
        <city>Venlo</city>
        <state>Limburg</state>
        <zip>5912 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VieCuri Medical Centre</investigator_affiliation>
    <investigator_full_name>Braim Rahel</investigator_full_name>
    <investigator_title>Dr. B.M. Rahel, Principal investigator, Cardiologist</investigator_title>
  </responsible_party>
  <keyword>Troponin</keyword>
  <keyword>Point-of-care</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>Siemens</keyword>
  <keyword>Chest pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458155
org study id: Study number 580
secondary id: METCZ20200008
secondary id: NL72445.096.20
nct id: NCT04458155
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Sample comparison
time frame: 30 days
description: 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.
measure: Bland-Altman method
time frame: 30 days
description: 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.
measure: Linear regression and Pearson's correlation.
time frame: 30 days
description: The relationship between POC sample types by linear regression and Pearson's correlation.
measure: Overview baseline characteristics.
time frame: 30 days
description: To create an overview of baseline characteristics of the population.
measure: Major adverse cardiac event (MACE)
time frame: 30 days
description: MACE is is defined as a composite of cardiac death and myocardial infarction.
measure: Modified HEART score
time frame: 30 days
description: To determine the modified HEART score retrospectively based upon POC capillary results in the population.
measure: Modified HEART score comparison
time frame: 30 days
description: 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.
arm group label: Chest pain patients
description: 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.
intervention type: Device
intervention name: Siemens® Point-of-care high sensitive troponin I analyzer
description: Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.
arm group label: Chest pain patients
Capillary blood, venous blood and blood plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Braim Rahel, Dr.
role: Principal Investigator
affiliation: VieCuri Medical Centre
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: VieCuri Medical Centre
investigator full name: Braim Rahel
investigator title: Dr. B.M. Rahel, Principal investigator, Cardiologist
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Infarction
mesh term: Ischemia
mesh term: Chest Pain
sharing ipd: Undecided