<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/NCT04506047</url>
  </required_header>
  <id_info>
    <org_study_id>570/11</org_study_id>
    <nct_id>NCT04506047</nct_id>
  </id_info>
  <brief_title>Acute and Long-term Outcomes of Patients With Acute Myocardial Infarction Treated With PCI</brief_title>
  <acronym>SINERGY-ACUTE</acronym>
  <official_title>Acute and Long-term Outcomes of Patients Presenting With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Centre of Serbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Cardiovascular Diseases Vojvodina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Hopital Center Zemun</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Medical Center Bezanijska Kosa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Centre of Kragujevac</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Hospital Center Zvezdara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Centre of Serbia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized studies may often be burdened by the selective nature of patient inclusion thus&#xD;
      not reflecting real-world outcomes. This is evident from the discrepancy in the mortality&#xD;
      rates reported in major randomized trials enrolling patients with acute myocardial infarction&#xD;
      (AMI), as compared with registry data.&#xD;
&#xD;
      The primary objective of this observational study is to assess short- and long-term outcomes&#xD;
      of unselected, real-world patients presenting with AMI and treated with contemporary&#xD;
      percutaneous coronary intervention (PCI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Other</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Rate of all-cause mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Rate of all-cause mortality at 1 year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of all-cause mortality</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of all-cause mortality at 5 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cardiovascular mortality</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of cardiovascular mortality at 5 years</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of myocardial infarction</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of myocardial infarction at 5 years</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of repeat revascularization</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of repeat revascularization at 5 years</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of stroke</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of stroke at 5 years</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of new or worsening heart failure</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of new or worsening heart failure at 5 years</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of new or worsening heart failure</measure>
    <time_frame>1 year</time_frame>
    <description>Rate of new or worsening heart failure at 1 year</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30000</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Acute Myocardial Infarction</arm_group_label>
    <description>Consecutive patients with acute myocardial infarction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Coronary Intervention</intervention_name>
    <description>Percutaneous Coronary Intervention</description>
    <arm_group_label>Acute Myocardial Infarction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This registry is based on consecutive patients with the initial diagnosis of acute&#xD;
        myocardial infarction on admission to hospital, who are referred to invasive treatment,&#xD;
        i.e. invasive coronary angiography with an intention to perform percutaneous coronary&#xD;
        intervention. The study population will include both retrospective, multi-center registry&#xD;
        data starting with the year 2009, and the prospectively enrolled patients according to the&#xD;
        same pre-specified, broad inclusion/exclusion criteria. The underlying intention is to&#xD;
        short- and long-term outcomes of a large population of unselected, real-world patients&#xD;
        presenting with AMI and treated with PCI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute myocardial infarction referred to catheterization laboratory for&#xD;
             percutaneous coronary intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Initial acute myocardial infarction diagnosis not confirmed&#xD;
&#xD;
          -  Patients with acute myocardial infarction not undergoing invasive coronary angiography&#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>Goran Stankovic, MD, PhD</last_name>
    <phone>+381113613653</phone>
    <email>gorastan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinical Centre of Serbia, Department of Cardiology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Goran Stankovic, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 12, 2022</last_update_submitted>
  <last_update_submitted_qc>March 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Centre of Serbia</investigator_affiliation>
    <investigator_full_name>Goran Stankovic</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>AMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04506047
org study id: 570/11
nct id: NCT04506047
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Randomized studies may often be burdened by the selective nature of patient inclusion thus
      not reflecting real-world outcomes. This is evident from the discrepancy in the mortality
      rates reported in major randomized trials enrolling patients with acute myocardial infarction
      (AMI), as compared with registry data.

      The primary objective of this observational study is to assess short- and long-term outcomes
      of unselected, real-world patients presenting with AMI and treated with contemporary
      percutaneous coronary intervention (PCI).
observational model: Cohort
time perspective: Other
measure: Rate of all-cause mortality
time frame: 1 year
description: Rate of all-cause mortality at 1 year
measure: Rate of all-cause mortality
time frame: 5 years
description: Rate of all-cause mortality at 5 years
measure: Rate of cardiovascular mortality
time frame: 5 years
description: Rate of cardiovascular mortality at 5 years
measure: Rate of myocardial infarction
time frame: 5 years
description: Rate of myocardial infarction at 5 years
measure: Rate of repeat revascularization
time frame: 5 years
description: Rate of repeat revascularization at 5 years
measure: Rate of stroke
time frame: 5 years
description: Rate of stroke at 5 years
measure: Rate of new or worsening heart failure
time frame: 5 years
description: Rate of new or worsening heart failure at 5 years
measure: Rate of new or worsening heart failure
time frame: 1 year
description: Rate of new or worsening heart failure at 1 year
arm group label: Acute Myocardial Infarction
description: Consecutive patients with acute myocardial infarction
intervention type: Procedure
intervention name: Percutaneous Coronary Intervention
description: Percutaneous Coronary Intervention
arm group label: Acute Myocardial Infarction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Goran Stankovic, MD, PhD
phone: +381113613653
email: gorastan@gmail.com
facility: 
status: Recruiting
contact: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: Clinical Centre of Serbia
investigator full name: Goran Stankovic
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: Undecided