<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/NCT03231527</url>
  </required_header>
  <id_info>
    <org_study_id>UG-002</org_study_id>
    <nct_id>NCT03231527</nct_id>
  </id_info>
  <brief_title>Outcomes of Total Arterial Coronary Artery Bypass Grafting</brief_title>
  <acronym>MOZART</acronym>
  <official_title>Multicentric Registry Database of Total Arterial CABG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thorax Centrum Twente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Golden Jubilee National Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Glasgow</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>
      &quot;real-life&quot; retrospective multicentric database for the analysis of the long term outcomes of&#xD;
      total arterial CABG in comparison to saphenous vein based CABG&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This aim of this registry is to create a multi centric database for the analysis of basic&#xD;
      long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison&#xD;
      to saphenous vein based CABG. The registry will include both on pump and off pump surgery.&#xD;
      The registry is intended to capture the &quot;real-life&quot; picture of the CABG scenario among&#xD;
      centers worldwide&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    research group's decision&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>data collection every year up to 5 years after operation/entry in the registry</time_frame>
    <description>Long term survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MACCEs</measure>
    <time_frame>data collection every year up to 5 years after operation/entry in the registry</time_frame>
    <description>Major cardiac events (myocardial infarction, stroke, readmission for CHF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>target vessel revascularization</measure>
    <time_frame>data collection every year up to 5 years after operation/entry in the registry</time_frame>
    <description>readmission for revascularization due to graft failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wound infection</measure>
    <time_frame>data collection every year up to 5 years after operation/entry in the registry</time_frame>
    <description>Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood product usage</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>unit of concentrated red cells, fresh frozen plasma, platelets</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>surgical bleeding requiring re-exploration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>number of days in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>number of days in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ventilation</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>number of hours ventilated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac complication</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>prolonged inotropic support (more than 48 hrs), IABP, ECMO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>pneumonia, reintubation, pneumothorax requiring drainage, effusion requiring drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal complications</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>acute kidney injury not requiring dyalisis, dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GI complications</measure>
    <time_frame>perioperative (in hospital)</time_frame>
    <description>mesenteric ischemia requiring surgery, ileus</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Surgical Wound Infection</condition>
  <arm_group>
    <arm_group_label>Total Arterial coronary CABG</arm_group_label>
    <description>Total Arterial revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saphenous vein based CABG</arm_group_label>
    <description>Saphenous vein based revascularization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>coronary artery bypass grafting (CABG)</intervention_name>
    <description>myocardial revascularization</description>
    <arm_group_label>Saphenous vein based CABG</arm_group_label>
    <arm_group_label>Total Arterial coronary CABG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary elective isolated CABG from multivessel coronary artery disease (CAD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal&#xD;
             mammary artery harvesting technique; open or endoscopic vein harvesting technique)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  urgent or emergent CABG&#xD;
&#xD;
          -  concomitant procedures&#xD;
&#xD;
          -  redo cases&#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>Cristiano Spadaccio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Golden Jubilee National Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Campus St Ian</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Campus Bio-Medico</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoracic Centrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Cristiano Spadaccio</investigator_full_name>
    <investigator_title>Cardiothoracic surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03231527
org study id: UG-002
nct id: NCT03231527
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"real-life" retrospective multicentric database for the analysis of the long term outcomes of
      total arterial CABG in comparison to saphenous vein based CABG
This aim of this registry is to create a multi centric database for the analysis of basic
      long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison
      to saphenous vein based CABG. The registry will include both on pump and off pump surgery.
      The registry is intended to capture the "real-life" picture of the CABG scenario among
      centers worldwide
observational model: Cohort
time perspective: Retrospective
measure: Survival
time frame: data collection every year up to 5 years after operation/entry in the registry
description: Long term survival
measure: MACCEs
time frame: data collection every year up to 5 years after operation/entry in the registry
description: Major cardiac events (myocardial infarction, stroke, readmission for CHF)
measure: target vessel revascularization
time frame: data collection every year up to 5 years after operation/entry in the registry
description: readmission for revascularization due to graft failure
measure: Wound infection
time frame: data collection every year up to 5 years after operation/entry in the registry
description: Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)
measure: Blood product usage
time frame: perioperative (in hospital)
description: unit of concentrated red cells, fresh frozen plasma, platelets
measure: Bleeding
time frame: perioperative (in hospital)
description: surgical bleeding requiring re-exploration
measure: Length of ICU stay
time frame: perioperative (in hospital)
description: number of days in ICU
measure: Length of hospital stay
time frame: perioperative (in hospital)
description: number of days in hospital
measure: Duration of ventilation
time frame: perioperative (in hospital)
description: number of hours ventilated
measure: Cardiac complication
time frame: perioperative (in hospital)
description: prolonged inotropic support (more than 48 hrs), IABP, ECMO
measure: Respiratory complications
time frame: perioperative (in hospital)
description: pneumonia, reintubation, pneumothorax requiring drainage, effusion requiring drainage
measure: Renal complications
time frame: perioperative (in hospital)
description: acute kidney injury not requiring dyalisis, dialysis
measure: GI complications
time frame: perioperative (in hospital)
description: mesenteric ischemia requiring surgery, ileus
arm group label: Total Arterial coronary CABG
description: Total Arterial revascularization
arm group label: Saphenous vein based CABG
description: Saphenous vein based revascularization
intervention type: Procedure
intervention name: coronary artery bypass grafting (CABG)
description: myocardial revascularization
arm group label: Saphenous vein based CABG
arm group label: Total Arterial coronary CABG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristiano Spadaccio, MD, PhD
role: Principal Investigator
affiliation: Golden Jubilee National Hospital
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Netherlands
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Cristiano Spadaccio
investigator title: Cardiothoracic surgeon
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Coronary Artery Disease
mesh term: Surgical Wound
sharing ipd: No