<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/NCT03227159</url>
  </required_header>
  <id_info>
    <org_study_id>837.075.06</org_study_id>
    <nct_id>NCT03227159</nct_id>
  </id_info>
  <brief_title>Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis</brief_title>
  <acronym>stenoCARDIA</acronym>
  <official_title>Study for Evaluation of Newly Onset Chest Pain and Rapid Diagnosis of Myocardial Necrosis (stenoCARDIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</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 is a national multi-center, prospective surveillance study in patients with suspected&#xD;
      acute coronary syndrome. Eligible patients must present to one of the participating Emergency&#xD;
      Departments within 24 hours from the time of symptom onset. Approximately 2000 patients &gt;18&#xD;
      and &lt;85 years of age are planned to be enrolled.&#xD;
&#xD;
      Upon enrollment in the Emergency Department, a venous blood sample will be obtained from each&#xD;
      patient for analysis. The patient's diagnostic work-up, treatment and disposition will&#xD;
      continue per the standards of the treating institution. Results will be recorded for ECGs,&#xD;
      any cardiac biomarkers measured at the site and any follow-up cardiac objective tests&#xD;
      performed for evidence of coronary artery disease and/or myocardial damage (exercise&#xD;
      treadmill, coronary angiography, cardiac thallium or technetium scintigraphy, etc).&#xD;
&#xD;
      The Principal Investigator at each site will evaluate the results of the diagnostic cardiac&#xD;
      tests performed for that patient to determine whether each patient enrolled at their site has&#xD;
      a final diagnosis of ACS.&#xD;
&#xD;
      The status of each patient will also be assessed at 1 month and 6 months after enrollment for&#xD;
      intercurrent Major Adverse Cardiac Events (MACE), including myocardial infarction, cardiac&#xD;
      revascularization and death.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2007</start_date>
  <completion_date type="Actual">December 31, 2008</completion_date>
  <primary_completion_date type="Actual">December 31, 2008</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>Diagnosis of acute coronary syndromes</measure>
    <time_frame>30 days</time_frame>
    <description>The primary end-point of the study is the early diagnosis of acute coronary syndromes using a combined analysis of multiple markers compared to single marker analyses (final diagnosis of ACS as reason for hospital admission).</description>
  </primary_outcome>
  <enrollment type="Actual">1818</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  A venous blood sample (10 ml EDTA, 10ml Citrate, 10ml Serum) for storage and further&#xD;
           analysis&#xD;
&#xD;
        -  A venous blood sample (10 ml EDTA ) DNA Analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will focus on patients presenting to the ED within 24 hours of the onset of&#xD;
        chest pain. Both patients then discharged to home as well as patients subsequently admitted&#xD;
        to the hospital are eligible for the study and may be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only patients who are able to give consent. This has to be carefully verified in each&#xD;
             case, by the doctors leading the study&#xD;
&#xD;
          -  Men or women &gt;18 and &lt;85 years of age&#xD;
&#xD;
          -  Patients with chest discomfort within last 24h and suspected Acute Coronary Syndrome&#xD;
             (STEMI, NSTEMI and unstable angina)&#xD;
&#xD;
          -  Patient experiencing at least 30 minutes of chest discomfort or other symptoms&#xD;
             consistent with possible ACS; (Note: Patients who have symptoms of shorter duration&#xD;
             that resolved due to pharmacologic intervention may be included.)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 or &gt;85 years&#xD;
&#xD;
          -  Inpatient in the hospital prior to onset of symptoms.&#xD;
&#xD;
          -  Obvious traumatic disease&#xD;
&#xD;
          -  Prisoners or other institutionalized or vulnerable individuals&#xD;
&#xD;
          -  Major surgery within last 4 weeks&#xD;
&#xD;
          -  Patients with cardiogenic shock&#xD;
&#xD;
          -  Other significant laboratory abnormalities that the investigator feels may compromise&#xD;
             the patient's safety by participation in the study&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Obvious iv drug abuse&#xD;
&#xD;
          -  Refusal to provide written informed consent&#xD;
&#xD;
          -  Unavailability of a telephone number and insufficient contact information as well as&#xD;
             permanent residence abroad&#xD;
&#xD;
          -  Unreliability as a study participant as based on the investigator's prior knowledge of&#xD;
             the patient, such as the inability or willingness to participate in or complete the&#xD;
             study or the presence of concurrent physical or psychological disorders that may make&#xD;
             it impractical for the patient to participate in or complete the study&#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>Stefan Blankenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Heart Center Hamburg</affiliation>
  </overall_official>
  <results_reference>
    <citation>Keller T, Zeller T, Ojeda F, Tzikas S, Lillpopp L, Sinning C, Wild P, Genth-Zotz S, Warnholtz A, Giannitsis E, Mockel M, Bickel C, Peetz D, Lackner K, Baldus S, Munzel T, Blankenberg S. Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. JAMA. 2011 Dec 28;306(24):2684-93. doi: 10.1001/jama.2011.1896.</citation>
    <PMID>22203537</PMID>
  </results_reference>
  <results_reference>
    <citation>Keller T, Zeller T, Peetz D, Tzikas S, Roth A, Czyz E, Bickel C, Baldus S, Warnholtz A, Frohlich M, Sinning CR, Eleftheriadis MS, Wild PS, Schnabel RB, Lubos E, Jachmann N, Genth-Zotz S, Post F, Nicaud V, Tiret L, Lackner KJ, Munzel TF, Blankenberg S. Sensitive troponin I assay in early diagnosis of acute myocardial infarction. N Engl J Med. 2009 Aug 27;361(9):868-77. doi: 10.1056/NEJMoa0903515.</citation>
    <PMID>19710485</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Myocardial Infarction</keyword>
  <keyword>Troponin</keyword>
  <keyword>Emergency department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Necrosis</mesh_term>
    <mesh_term>Chest Pain</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/NCT03227159
org study id: 837.075.06
nct id: NCT03227159
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a national multi-center, prospective surveillance study in patients with suspected
      acute coronary syndrome. Eligible patients must present to one of the participating Emergency
      Departments within 24 hours from the time of symptom onset. Approximately 2000 patients >18
      and <85 years of age are planned to be enrolled.

      Upon enrollment in the Emergency Department, a venous blood sample will be obtained from each
      patient for analysis. The patient's diagnostic work-up, treatment and disposition will
      continue per the standards of the treating institution. Results will be recorded for ECGs,
      any cardiac biomarkers measured at the site and any follow-up cardiac objective tests
      performed for evidence of coronary artery disease and/or myocardial damage (exercise
      treadmill, coronary angiography, cardiac thallium or technetium scintigraphy, etc).

      The Principal Investigator at each site will evaluate the results of the diagnostic cardiac
      tests performed for that patient to determine whether each patient enrolled at their site has
      a final diagnosis of ACS.

      The status of each patient will also be assessed at 1 month and 6 months after enrollment for
      intercurrent Major Adverse Cardiac Events (MACE), including myocardial infarction, cardiac
      revascularization and death.
observational model: Cohort
time perspective: Prospective
measure: Diagnosis of acute coronary syndromes
time frame: 30 days
description: The primary end-point of the study is the early diagnosis of acute coronary syndromes using a combined analysis of multiple markers compared to single marker analyses (final diagnosis of ACS as reason for hospital admission).
-  A venous blood sample (10 ml EDTA, 10ml Citrate, 10ml Serum) for storage and further
           analysis

        -  A venous blood sample (10 ml EDTA ) DNA Analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan Blankenberg, MD
role: Principal Investigator
affiliation: University Heart Center Hamburg
citation: Keller T, Zeller T, Ojeda F, Tzikas S, Lillpopp L, Sinning C, Wild P, Genth-Zotz S, Warnholtz A, Giannitsis E, Mockel M, Bickel C, Peetz D, Lackner K, Baldus S, Munzel T, Blankenberg S. Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction. JAMA. 2011 Dec 28;306(24):2684-93. doi: 10.1001/jama.2011.1896.
PMID: 22203537
citation: Keller T, Zeller T, Peetz D, Tzikas S, Roth A, Czyz E, Bickel C, Baldus S, Warnholtz A, Frohlich M, Sinning CR, Eleftheriadis MS, Wild PS, Schnabel RB, Lubos E, Jachmann N, Genth-Zotz S, Post F, Nicaud V, Tiret L, Lackner KJ, Munzel TF, Blankenberg S. Sensitive troponin I assay in early diagnosis of acute myocardial infarction. N Engl J Med. 2009 Aug 27;361(9):868-77. doi: 10.1056/NEJMoa0903515.
PMID: 19710485
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Necrosis
mesh term: Chest Pain