<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/NCT01698021</url>
  </required_header>
  <id_info>
    <org_study_id>Projet 12-081</org_study_id>
    <nct_id>NCT01698021</nct_id>
  </id_info>
  <brief_title>Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome</brief_title>
  <acronym>QUANTUM</acronym>
  <official_title>Quantification and Description of the Increase in Serum Troponin Following Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Sherbrooke</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The new assay of troponins T (highly sensitive troponins) detects concentrations much lower&#xD;
      than before. Few data are currently available on their kinetics during acute coronary&#xD;
      syndrome, especially in regard to the correlation with CK MB. The aim of the present study is&#xD;
      to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to&#xD;
      correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value&#xD;
      with respect to infarct size .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who meet the inclusion criteria will have a highly sensitive troponins and CKMB&#xD;
      assays q 8hr for the first day, and q 12h for the next 2 days. If clinically not indicated,&#xD;
      the blood sample can be cancelled at any time, as in the case of a patient with an initial&#xD;
      suspicion of acute coronary syndrome in which the final diagnosis is something else. Only&#xD;
      patients with a definitive myocardial infarction will be analyzed.&#xD;
&#xD;
      Subgroup analyses includes ST-elevation MI, Non ST-elevation MI, revascularization vs no&#xD;
      revascularization, procedural myocardial infarction.&#xD;
&#xD;
      Another analysis conducted is the correlation between the values of troponin and infarct size&#xD;
      by echocardiography (in patients who have an echocardiography 2-7 days post AND 2-6 months&#xD;
      post myocardial infarction)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">November 2013</completion_date>
  <primary_completion_date type="Anticipated">November 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of troponins kinetic in acute coronary syndromes.</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Unstable Angina</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients presenting to the emergency department or being hospitalized for&#xD;
        any reason in which we suspect an acute coronary syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;= 18 years-old&#xD;
&#xD;
          -  Clinical suspicion of an acute coronary syndrome; (will be analyzed only patients with&#xD;
             aposteriori definitive diagnosis of unstable angina or myocardial infarction)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>Paul Farand, Md MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de recherche du Centre hospitalier universitaire de Sherbrooke</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul Farand, MD MSc</last_name>
    <phone>(819) 346-1110</phone>
    <phone_ext>9093 pagette</phone_ext>
    <email>paul.farand@usherbrooke.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francis Bonenfant, resident</last_name>
    <phone>(819) 346-1110</phone>
    <phone_ext>4987 pagette</phone_ext>
    <email>francis.bonenfant@usherbrooke.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Farand, MD MSc</last_name>
      <phone>(819) 346-1110</phone>
      <phone_ext>9093 pagette</phone_ext>
      <email>paul.farand@usherbrooke.ca</email>
    </contact>
    <contact_backup>
      <last_name>Francis Bonenfant, MD</last_name>
      <phone>(819) 346-1110</phone>
      <phone_ext>4987</phone_ext>
      <email>francis.bonenfant@usherbrooke.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Paul Farand, MD MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>June 25, 2013</last_update_submitted>
  <last_update_submitted_qc>June 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Creatine Kinase, MB form</keyword>
  <keyword>Troponin</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>myocardial infarction</keyword>
  <keyword>Unstable angina</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>Angina, Unstable</mesh_term>
    <mesh_term>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/NCT01698021
org study id: Projet 12-081
nct id: NCT01698021
lead sponsor: 
has dmc: No
The new assay of troponins T (highly sensitive troponins) detects concentrations much lower
      than before. Few data are currently available on their kinetics during acute coronary
      syndrome, especially in regard to the correlation with CK MB. The aim of the present study is
      to describe the kinetic of highly sensitive troponins in acute coronary syndrome, to
      correlate it with the concentration of CK MB, and possibly to evaluate their prognostic value
      with respect to infarct size .
Patients who meet the inclusion criteria will have a highly sensitive troponins and CKMB
      assays q 8hr for the first day, and q 12h for the next 2 days. If clinically not indicated,
      the blood sample can be cancelled at any time, as in the case of a patient with an initial
      suspicion of acute coronary syndrome in which the final diagnosis is something else. Only
      patients with a definitive myocardial infarction will be analyzed.

      Subgroup analyses includes ST-elevation MI, Non ST-elevation MI, revascularization vs no
      revascularization, procedural myocardial infarction.

      Another analysis conducted is the correlation between the values of troponin and infarct size
      by echocardiography (in patients who have an echocardiography 2-7 days post AND 2-6 months
      post myocardial infarction)
observational model: Cohort
time perspective: Prospective
measure: Evaluation of troponins kinetic in acute coronary syndromes.
time frame: 72 hours
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Farand, Md MSc
role: Principal Investigator
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
last name: Paul Farand, MD MSc
phone: (819) 346-1110
phone ext: 9093 pagette
email: paul.farand@usherbrooke.ca
last name: Francis Bonenfant, resident
phone: (819) 346-1110
phone ext: 4987 pagette
email: francis.bonenfant@usherbrooke.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Angina, Unstable
mesh term: Syndrome
mesh term: Infarction