<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/NCT03774004</url>
  </required_header>
  <id_info>
    <org_study_id>1098/2017</org_study_id>
    <nct_id>NCT03774004</nct_id>
  </id_info>
  <brief_title>Plaque Burden Pre- Myocardial Revascularisation</brief_title>
  <acronym>ByPlaque</acronym>
  <official_title>Association of Peripheral Atherosclerotic Burden With the Short-term and Long-term Outcome in Patients With Elective Myocardial Revascularisation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</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>
      The study is a prospective-observational, explorative single-centre cohort study aimed to&#xD;
      examine the influence of the peripheral atherosclerotic plaque volume on short and long term&#xD;
      morbidity and mortality in patient after coronary artery bypass grafting (CABG).&#xD;
&#xD;
      Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT&#xD;
      measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the&#xD;
      internal thoracic arteries will be evaluated additionally with US. These parameters will be&#xD;
      measured pre-CABG.&#xD;
&#xD;
      Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major&#xD;
      adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden&#xD;
      will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Association of MACE rates with peripheral atherosclerotic volume</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Association of morbidity with peripheral atherosclerotic volume</measure>
    <time_frame>5 years</time_frame>
    <description>Morbidity will be evaluated with quality of life assessment (&quot;EQ-5D-3L&quot;, &quot;IPAQ&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions</measure>
    <time_frame>1 year</time_frame>
    <description>Risk scores include STS Score and Euro Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of the duration of the operation with peripheral atherosclerotic volume</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of the aortic clamp time with peripheral atherosclerotic volume</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of the ICU stay with peripheral atherosclerotic volume</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of the hospitalization duration with peripheral atherosclerotic volume</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atherosclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients, who are are listed for elective CABG at the Medical University Innsbruck will be&#xD;
        screened and recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pre CABG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent, prior carotid intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Peter Marschang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Schreinlechner, MD</last_name>
    <phone>004351250481308</phone>
    <email>Michael.Schreinlechner@i-med.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peter Marschang, MD</last_name>
    <email>Peter.Marschang@i-med.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Schreinlechner, MD</last_name>
      <phone>004351250481308</phone>
      <email>Michael.Schreinlechner@i-med.ac.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</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>Atherosclerosis</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/NCT03774004
org study id: 1098/2017
nct id: NCT03774004
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective-observational, explorative single-centre cohort study aimed to
      examine the influence of the peripheral atherosclerotic plaque volume on short and long term
      morbidity and mortality in patient after coronary artery bypass grafting (CABG).

      Atherosclerotic disease (IMT, plaque volume) will be measured with a ultrasound system (IMT
      measurements and 3D quantitative plaque volumetric). Hemodynamic and flow profiles of the
      internal thoracic arteries will be evaluated additionally with US. These parameters will be
      measured pre-CABG.

      Morbidity will be evaluated using quality of life questionnaires (EQ-5D-3L, IPAQ). Major
      adverse cardiovascular events (MACE) will be the primary endpoint. The atherosclerotic burden
      will be compared with established risk scores (EuroSCORE, STS-Score, SYNTAX Score, FORECAST.
observational model: Cohort
time perspective: Prospective
measure: Association of MACE rates with peripheral atherosclerotic volume
time frame: 5 years
measure: Association of morbidity with peripheral atherosclerotic volume
time frame: 5 years
description: Morbidity will be evaluated with quality of life assessment ("EQ-5D-3L", "IPAQ"
measure: Comparison of predictive value of peripheral atherosclerotic volume with established risk scores for cardiovascular operations and interventions
time frame: 1 year
description: Risk scores include STS Score and Euro Score
measure: Association of the duration of the operation with peripheral atherosclerotic volume
time frame: 30 days
measure: Association of flow profiles of internal mammary artery with LIMA/RIMA graft patency rates
time frame: 5 years
measure: Association of the aortic clamp time with peripheral atherosclerotic volume
time frame: 30 days
measure: Association of the ICU stay with peripheral atherosclerotic volume
time frame: 30 days
measure: Association of the hospitalization duration with peripheral atherosclerotic volume
time frame: 30 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
last name: Peter Marschang, MD
role: Principal Investigator
affiliation: Medical University Innsbruck
last name: Michael Schreinlechner, MD
phone: 004351250481308
email: Michael.Schreinlechner@i-med.ac.at
last name: Peter Marschang, MD
email: Peter.Marschang@i-med.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor
mesh term: Atherosclerosis