<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/NCT02191735</url>
  </required_header>
  <id_info>
    <org_study_id>CSP024</org_study_id>
    <nct_id>NCT02191735</nct_id>
  </id_info>
  <brief_title>RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care</brief_title>
  <acronym>C-POC</acronym>
  <official_title>Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Response Biomedical Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Response Biomedical Corp.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical investigation is designed to demonstrate the performance characteristics of the&#xD;
      RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the&#xD;
      point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.</measure>
    <time_frame>method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.</time_frame>
    <description>The primary objective is to achieve substantial equivalence of the RAMP® cardiac tests on the RAMP® Reader and the RAMP® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications:&#xD;
precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials;&#xD;
precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and,&#xD;
performance via method comparison across the reportable ranges of the RAMP® cardiac tests.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">719</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Heart Failure</condition>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Troponin I</arm_group_label>
    <description>Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Myoglobin</arm_group_label>
    <description>Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP Myoglobin test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CK-MB</arm_group_label>
    <description>Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP CK-MB test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NT-proBNP</arm_group_label>
    <description>Subjects who have undergone a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RAMP 200</intervention_name>
    <description>The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.</description>
    <arm_group_label>CK-MB</arm_group_label>
    <arm_group_label>Myoglobin</arm_group_label>
    <arm_group_label>NT-proBNP</arm_group_label>
    <arm_group_label>Troponin I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RAMP Reader</intervention_name>
    <description>The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.</description>
    <arm_group_label>CK-MB</arm_group_label>
    <arm_group_label>Myoglobin</arm_group_label>
    <arm_group_label>NT-proBNP</arm_group_label>
    <arm_group_label>Troponin I</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA plamsa specimens&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 600 total subjects, 18 years of age and older will be enrolled into this&#xD;
        study at a minimum of 3 sites in the United States of America (USA).&#xD;
&#xD;
        Each site will screen for a minimum of approximately 200 clinical surplus whole blood&#xD;
        samples derived from subjects presenting with symptoms and signs indicative of&#xD;
        cardiovascular heart disease (i.e. acute myocardial infarction and/or heart failure). It is&#xD;
        expected that the population will be divided approximately equally between males and&#xD;
        females. Clinical site enrollment will be monitored throughout the trial to verify&#xD;
        population distribution.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Study Arms A - Troponin I (ACS/MI)&#xD;
&#xD;
          1. Males or Females, 18 years of age or older, of any race&#xD;
&#xD;
          2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome /&#xD;
             Myocardial Infarction (ACS/MI) - as per institutional guidelines&#xD;
&#xD;
          3. Willing to voluntarily agree to sign a consent form (if applicable)&#xD;
&#xD;
        Study Arms B - Myoglobin (ACS/MI)&#xD;
&#xD;
          1. Males or Females, 18 years of age or older, of any race&#xD;
&#xD;
          2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome /&#xD;
             Myocardial Infarction (ACS/MI) - as per institutional guidelines&#xD;
&#xD;
          3. Myoglobin test result falls within the reportable range of the test as reported in the&#xD;
             RAMP® Myoglobin IFU.&#xD;
&#xD;
          4. Willing to voluntarily agree to sign a consent form (if applicable)&#xD;
&#xD;
        Study Arms C - CK-MB (ACS/MI)&#xD;
&#xD;
          1. Males or Females, 18 years of age or older, of any race&#xD;
&#xD;
          2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome /&#xD;
             Myocardial Infarction (ACS/MI) - as per institutional guidelines&#xD;
&#xD;
          3. CK-MB test result falls within the reportable range of the test as reported in the&#xD;
             RAMP® CK-MB IFU.&#xD;
&#xD;
          4. Willing to voluntarily agree to sign a consent form (if applicable)&#xD;
&#xD;
        Study Arm D - NT-proBNP (HF)&#xD;
&#xD;
          1. Males or Females, 18 years of age or older, of any race&#xD;
&#xD;
          2. Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as&#xD;
             per institutional guidelines&#xD;
&#xD;
          3. Willing to voluntarily agree to sign a consent form (if applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)&#xD;
&#xD;
          1. Healthy Subjects&#xD;
&#xD;
          2. Pregnant or lactating&#xD;
&#xD;
          3. Subjects not having a cardiac marker test ordered&#xD;
&#xD;
          4. Blood sample collected &gt;24 hours prior to screening&#xD;
&#xD;
          5. Subjects without adequate volumes of surplus EDTA whole blood available for all&#xD;
             required trial testing&#xD;
&#xD;
          6. Non-compliance to the protocol or the inclusion criteria&#xD;
&#xD;
        Study Arm D - NT-proBNP (HF)&#xD;
&#xD;
          1. Healthy Subjects&#xD;
&#xD;
          2. Pregnant or lactating&#xD;
&#xD;
          3. Subjects not having a cardiac marker test ordered&#xD;
&#xD;
          4. Blood sample collected &gt;24 hours prior to screening&#xD;
&#xD;
          5. Subjects without adequate volumes of surplus EDTA whole blood available for all&#xD;
             required trial testing&#xD;
&#xD;
          6. Non-compliance to the protocol or the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert H Christenson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco General Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Medical Research Foundation</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>January 7, 2015</last_update_submitted>
  <last_update_submitted_qc>January 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02191735
org study id: CSP024
nct id: NCT02191735
lead sponsor: 
has dmc: No
This clinical investigation is designed to demonstrate the performance characteristics of the
      RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the
      point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.
observational model: Cohort
time perspective: Retrospective
measure: Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.
time frame: method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.
description: The primary objective is to achieve substantial equivalence of the RAMP® cardiac tests on the RAMP® Reader and the RAMP® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications:
precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials;
precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and,
performance via method comparison across the reportable ranges of the RAMP® cardiac tests.
arm group label: Troponin I
description: Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
arm group label: Myoglobin
description: Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP Myoglobin test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
arm group label: CK-MB
description: Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP CK-MB test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
arm group label: NT-proBNP
description: Subjects who have undergone a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
intervention type: Device
intervention name: RAMP 200
description: The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.
arm group label: CK-MB
arm group label: Myoglobin
arm group label: NT-proBNP
arm group label: Troponin I
intervention type: Device
intervention name: RAMP Reader
description: The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.
arm group label: CK-MB
arm group label: Myoglobin
arm group label: NT-proBNP
arm group label: Troponin I
EDTA plamsa specimens
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert H Christenson, PhD
role: Principal Investigator
affiliation: University of Maryland Medical Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Infarction