<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/NCT01724996</url>
  </required_header>
  <id_info>
    <org_study_id>CP1</org_study_id>
    <nct_id>NCT01724996</nct_id>
  </id_info>
  <brief_title>Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups</brief_title>
  <official_title>Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the significance of a simple bedside clinical test (chest wall tenderness) to&#xD;
      exclude myocardial ischemia in different demographic groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When a patient is presenting with acute chest pain at the ER of the University Hospital of&#xD;
      Zurich, the study physician in charge, who is acting simultaneously as one of four attending&#xD;
      clinical physicians, is performing the physical examination according to routine clinical&#xD;
      practice. The physical examination includes the testing of chest wall tenderness: Palpation&#xD;
      of chest wall tenderness in lying 30° elevation of chest position. Flat index with&#xD;
      standardized pressure where spontaneous maximum pain is reported (reproducible vs. not&#xD;
      reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle&#xD;
      intercostal 6/7), reproducible vs. not reproducible pain vs. no pain. The same physician, who&#xD;
      is blinded for the final diagnosis at the time of the physical examination, is also recording&#xD;
      the patient history including the study interview using the standardized study questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">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>Chest wall tenderness</measure>
    <time_frame>From first presententation to omission (6-12 hours)</time_frame>
    <description>Chest wall tenderness in patients presenting with acute chest pain and acute coronary syndrome (ACS) (ST-elevation myocardial infarction, STEMI/Non-ST-elevation myocardial infarction, NSTEMI /unstable angina pectoris) vs. chest wall tenderness in patients presenting with chest pain and without ACS in different demographic groups (Age under vs. over 50 years; male vs. female, with vs. without CVRF).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain description</measure>
    <time_frame>6-12 hours</time_frame>
    <description>Localization/Radiation of pain/first time/recurrent/ Patient thinks heart is the cause/ different CVRF/Illicit drugs/Medication - in combination with &quot;reproducible/not reproducible pain&quot; associated with ACS</description>
  </secondary_outcome>
  <enrollment type="Actual">110</enrollment>
  <condition>Chest Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical examination: chest wall tenderness</intervention_name>
    <description>The physical examination includes the testing of chest wall tenderness: Palpation of chest wall tenderness in lying 30° elevation of chest position. Flat index with standardized pressure where spontaneous maximum pain is reported (reproducible vs. not reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle intercostal 6/7), reproducible vs. not reproducible pain vs. no pain.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patiens seaking the Emergency room of the University Hospital Zurich because of chest pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria: All patients over the age of 18 years presenting with the leading&#xD;
        symptom of first time or recurrent acute chest pain in the emergency room of the Department&#xD;
        of Internal Medicine, University Hospital of Zurich.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Missing informed consent.&#xD;
&#xD;
          -  Cardiopulmonary unstable patients.&#xD;
&#xD;
          -  No self reported chest pain.&#xD;
&#xD;
          -  Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia,&#xD;
             cardiogenic shock.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Franzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Internal Medicine</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>May 26, 2014</last_update_submitted>
  <last_update_submitted_qc>May 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</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>Acute Coronary Syndrome</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/NCT01724996
org study id: CP1
nct id: NCT01724996
lead sponsor: 
has dmc: No
To determine the significance of a simple bedside clinical test (chest wall tenderness) to
      exclude myocardial ischemia in different demographic groups.
When a patient is presenting with acute chest pain at the ER of the University Hospital of
      Zurich, the study physician in charge, who is acting simultaneously as one of four attending
      clinical physicians, is performing the physical examination according to routine clinical
      practice. The physical examination includes the testing of chest wall tenderness: Palpation
      of chest wall tenderness in lying 30° elevation of chest position. Flat index with
      standardized pressure where spontaneous maximum pain is reported (reproducible vs. not
      reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle
      intercostal 6/7), reproducible vs. not reproducible pain vs. no pain. The same physician, who
      is blinded for the final diagnosis at the time of the physical examination, is also recording
      the patient history including the study interview using the standardized study questionnaire.
observational model: Cohort
time perspective: Prospective
measure: Chest wall tenderness
time frame: From first presententation to omission (6-12 hours)
description: Chest wall tenderness in patients presenting with acute chest pain and acute coronary syndrome (ACS) (ST-elevation myocardial infarction, STEMI/Non-ST-elevation myocardial infarction, NSTEMI /unstable angina pectoris) vs. chest wall tenderness in patients presenting with chest pain and without ACS in different demographic groups (Age under vs. over 50 years; male vs. female, with vs. without CVRF).
measure: Pain description
time frame: 6-12 hours
description: Localization/Radiation of pain/first time/recurrent/ Patient thinks heart is the cause/ different CVRF/Illicit drugs/Medication - in combination with "reproducible/not reproducible pain" associated with ACS
intervention type: Other
intervention name: Clinical examination: chest wall tenderness
description: The physical examination includes the testing of chest wall tenderness: Palpation of chest wall tenderness in lying 30° elevation of chest position. Flat index with standardized pressure where spontaneous maximum pain is reported (reproducible vs. not reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle intercostal 6/7), reproducible vs. not reproducible pain vs. no pain.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Franzen, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Internal Medicine
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Chest Pain