xml: <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/NCT06023355</url>
    </required_header>
    <id_info>
      <org_study_id>2023/D/1066</org_study_id>
      <nct_id>NCT06023355</nct_id>
    </id_info>
    <brief_title>Sex-related Differences in Outcome After Hybrid Coronary Revascularization</brief_title>
    <acronym>SEX-HYBRID</acronym>
    <official_title>Sex-related Differences in Outcome After Hybrid Coronary Revascularization Versus Coronary Artery Bypass Grafting in Multivessel Coronary Artery Disease: The SEX-HYBRID Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Roma La Sapienza</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Roma La Sapienza</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>
        Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional&#xD;
        coronary artery bypass grafting (CABG) in a select group of patients with multivessel&#xD;
        coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG&#xD;
        have been carried out, but no data on the potential impact of sex on the outcome of HCR&#xD;
        exist.&#xD;
  &#xD;
        To fill this knowledge gap, the investigators aim to perform an international collaborative&#xD;
        multi-center study in order to examine gender differences in short-term and long-term&#xD;
        outcomes among patients who underwent HCR or CABG.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional&#xD;
        coronary artery bypass grafting (CABG) in a select group of patients with multivessel&#xD;
        coronary artery disease (CAD).&#xD;
  &#xD;
        Till date, multiple individual studies comparing HCR with CABG have been carried out, but no&#xD;
        data on the potential impact of sex on the outcome of HCR exist. Limited by their sample&#xD;
        size, these individual studies may have been under-powered to detect a difference.&#xD;
  &#xD;
        To fill this knowledge gap, the investigators aim to perform an international collaborative&#xD;
        multi-center study in order to examine gender differences in short-term and long-term&#xD;
        outcomes among patients who underwent HCR or CABG.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Incidence of Overall Mortality</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>All causes deaths</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Composite End-point</measure>
      <time_frame>Up to 1 year</time_frame>
      <description>Cardiac death, myocardial infarction, stroke, bleeding</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Coronary Artery Disease</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>HYBRID</intervention_name>
      <description>It involves the combination of a sternal sparing left internal mammary artery (LIMA) bypass and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for non-left anterior descending (LAD) lesions. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer in-hospital complications, and lower utilization of healthcare resources, while providing the key benefits of LIMA-LAD grafting.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with multivessel coronary artery disease and indication to cardiac surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with coronary artery disease and indication to cardiac surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Contraindications to cardiac surgery&#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_contact>
      <last_name>Francesco Pelliccia</last_name>
      <phone>+390633062615</phone>
      <email>f.pelliccia@mclink.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fabio Miraldi</last_name>
      <phone>+390633062615</phone>
      <email>f.pelliccia@mclink.it</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
      <investigator_full_name>Francesco Pelliccia</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023355
  org study id: 2023/D/1066
  nct id: NCT06023355
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional
        coronary artery bypass grafting (CABG) in a select group of patients with multivessel
        coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG
        have been carried out, but no data on the potential impact of sex on the outcome of HCR
        exist.
  
        To fill this knowledge gap, the investigators aim to perform an international collaborative
        multi-center study in order to examine gender differences in short-term and long-term
        outcomes among patients who underwent HCR or CABG.
  Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional
        coronary artery bypass grafting (CABG) in a select group of patients with multivessel
        coronary artery disease (CAD).
  
        Till date, multiple individual studies comparing HCR with CABG have been carried out, but no
        data on the potential impact of sex on the outcome of HCR exist. Limited by their sample
        size, these individual studies may have been under-powered to detect a difference.
  
        To fill this knowledge gap, the investigators aim to perform an international collaborative
        multi-center study in order to examine gender differences in short-term and long-term
        outcomes among patients who underwent HCR or CABG.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of Overall Mortality
  time frame: Up to 1 year
  description: All causes deaths
  measure: Incidence of Composite End-point
  time frame: Up to 1 year
  description: Cardiac death, myocardial infarction, stroke, bleeding
  intervention type: Procedure
  intervention name: HYBRID
  description: It involves the combination of a sternal sparing left internal mammary artery (LIMA) bypass and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for non-left anterior descending (LAD) lesions. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer in-hospital complications, and lower utilization of healthcare resources, while providing the key benefits of LIMA-LAD grafting.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Francesco Pelliccia
  phone: +390633062615
  email: f.pelliccia@mclink.it
  last name: Fabio Miraldi
  phone: +390633062615
  email: f.pelliccia@mclink.it
  responsible party type: Principal Investigator
  investigator affiliation: University of Roma La Sapienza
  investigator full name: Francesco Pelliccia
  investigator title: Associate Professor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: Undecided