<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/NCT03787797</url>
  </required_header>
  <id_info>
    <org_study_id>18-8402-BO</org_study_id>
    <nct_id>NCT03787797</nct_id>
  </id_info>
  <brief_title>Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients</brief_title>
  <acronym>EPIC-ACS</acronym>
  <official_title>Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</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>
      Epicardial adipose tissue (EAT) is a visceral adipose tissue that surrounds the heart and the&#xD;
      coronary arteries. It is metabolically active, secreting pro- and anti-inflammatory mediators&#xD;
      and cytokines. With increasing EAT volume, inflammatory activity increasing, which suggests&#xD;
      that EAT may locally influence atherosclerosis development in the coronary artery tree. The&#xD;
      amount of EAT is associated with cardiovascular disease risk factors as well as presence and&#xD;
      progression of subclinical atherosclerosis. Likewise, EAT volume is increased in patient with&#xD;
      prevalent and incident coronary artery disease manifestation. In the setting of acute&#xD;
      coronary syndrome, EAT was found to be associated with the TIMI risk score and Syntax II&#xD;
      score. While CT imaging of the heart is the gold standard for EAT quantification,&#xD;
      transthoracic echocardiography allows for a quick and reliable assessment of EAT thickness,&#xD;
      as has been used in research studies and may qualify for routine EAT assessment in clinical&#xD;
      routine.However, currently data on how quantification of EAT in clinical routine may impact&#xD;
      patient management is lacking. We aim to investigate, whether quantification of EAT thickness&#xD;
      via transthoracic echocardiography enables improved risk stratification in patients&#xD;
      presenting with acute chest pain to the emergency department.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">August 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 14, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Coronary revascularization</measure>
    <time_frame>within 90 days after initial presentation</time_frame>
    <description>Number of Participants with need for coronary revascularization therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Invasive coronary angiography</measure>
    <time_frame>within 90 days after initial presentation</time_frame>
    <description>Number of Participants undergoing invasive coronary angiography</description>
  </secondary_outcome>
  <enrollment type="Actual">657</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Assessment of epicardial adipose tissue thickness</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion of patients without known coronary artery disease undergoing workup for suspected&#xD;
        acute coronary syndrome at the emergency department of the University Hospital Essen.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admission to the emergency department of the University Hospital Essen with acute&#xD;
             chest pain suggestive of an acute coronary syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known obstructive coronary artery disease prior to presentation, prior&#xD;
             revascularization therapy, unwillingness to provide informed consent&#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>Amir A Mahabadi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Essen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>4</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Amir Abbas Mahabadi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Epicardial adipose tissue</keyword>
  <keyword>Chest pain</keyword>
  <keyword>Echocardiography</keyword>
  <keyword>Coronary artery disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be made available upon request.</ipd_description>
  </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/NCT03787797
org study id: 18-8402-BO
nct id: NCT03787797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epicardial adipose tissue (EAT) is a visceral adipose tissue that surrounds the heart and the
      coronary arteries. It is metabolically active, secreting pro- and anti-inflammatory mediators
      and cytokines. With increasing EAT volume, inflammatory activity increasing, which suggests
      that EAT may locally influence atherosclerosis development in the coronary artery tree. The
      amount of EAT is associated with cardiovascular disease risk factors as well as presence and
      progression of subclinical atherosclerosis. Likewise, EAT volume is increased in patient with
      prevalent and incident coronary artery disease manifestation. In the setting of acute
      coronary syndrome, EAT was found to be associated with the TIMI risk score and Syntax II
      score. While CT imaging of the heart is the gold standard for EAT quantification,
      transthoracic echocardiography allows for a quick and reliable assessment of EAT thickness,
      as has been used in research studies and may qualify for routine EAT assessment in clinical
      routine.However, currently data on how quantification of EAT in clinical routine may impact
      patient management is lacking. We aim to investigate, whether quantification of EAT thickness
      via transthoracic echocardiography enables improved risk stratification in patients
      presenting with acute chest pain to the emergency department.
observational model: Cohort
time perspective: Prospective
measure: Coronary revascularization
time frame: within 90 days after initial presentation
description: Number of Participants with need for coronary revascularization therapy
measure: Invasive coronary angiography
time frame: within 90 days after initial presentation
description: Number of Participants undergoing invasive coronary angiography
intervention type: Diagnostic Test
intervention name: Echocardiography
description: Assessment of epicardial adipose tissue thickness
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amir A Mahabadi, MD
role: Principal Investigator
affiliation: University Hospital, Essen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Amir Abbas Mahabadi
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: Yes
ipd description: IPD will be made available upon request.