<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/NCT03263949</url>
  </required_header>
  <id_info>
    <org_study_id>1533/17</org_study_id>
    <nct_id>NCT03263949</nct_id>
  </id_info>
  <brief_title>Predicting Ventricular Tachyarrhythmias Following Acute ST Elevation Myocardial Infarction</brief_title>
  <acronym>PREDICT-VT</acronym>
  <official_title>Predicting Ventricular Tachyarrhythmias Following Acute ST Elevation Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Centre of Serbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Centre of Serbia</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>
      Predict-VT is an investigator-initiated, prospective, observational clinical trial. Four&#xD;
      hundred patients with ST elevation acute myocardial infarction (STEMI) undergoing primary&#xD;
      percutaneous coronary intervention (PPCI) will be included. The primary end point is a&#xD;
      composite of ventricular tachyarrhythmia (VTA) and sudden cardiac death (SCD). VTAs will be&#xD;
      recorded using continuous electrocardiographic (ECG) monitoring in the coronary unit for the&#xD;
      first 72 hours, standard ECG and ECG holter monitoring. For the analysis of myocardial&#xD;
      function, conventional 2D echocardiography and tissue doppler will be used. For the&#xD;
      evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical&#xD;
      dispersion will be obtained. Important clinical, laboratory and angiographic variables will&#xD;
      also be examined. Patients will be followed-up at 40 days and 1 year. The optimal VTA&#xD;
      prediction model will be constructed using logistic regression and bootstrap models. Patients&#xD;
      who experience primary end point should undergo secondary SCD prevention using implantable&#xD;
      cardioverter defibrillator (ICD). Patients with left ventricular ejection fraction (LVEF) &lt;&#xD;
      35%, 40 days post acute myocardial infarction (AMI), will be candidates for primary SCD&#xD;
      prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design Predict-VT is an investigator-initiated, prospective, open-label, single-center&#xD;
      clinical trial. The research protocol has been approved by the Ethics Committee of the&#xD;
      Clinical Center of Serbia. All participants will have to provide their informed consent in&#xD;
      writing. The trial design will ensure that all participants abide by good clinical practice&#xD;
      and the ethical principles of the Declaration of Helsinki II.&#xD;
&#xD;
      Study population The study will include at least 400 patients with acute myocardial&#xD;
      infarction with ST elevation (STEMI) who are elgible for treatment with primary percutaneous&#xD;
      coronary intervention (PPCI) within 12 hours from the onset of symptoms. Enrollment started&#xD;
      on January 2017 . Recruitment will continue until 400 patients have been randomized. The end&#xD;
      of the recruitment period is planned for January 2021. The trial will continue until all&#xD;
      available survivors have been followed for at least 1 year.&#xD;
&#xD;
      Objectives, end points and definitions The primary objective of PREDICT-VT trial is to test&#xD;
      the hypothesis that the occurrence of ventricular tachyarrhythmias (VTA) and sudden cardiac&#xD;
      death (SCD) is predictable with acceptable accuracy among STEMI patients undergoing PPCI.&#xD;
      Therefore, the PREDICT-VT specified primary end point is the analysis of independent&#xD;
      predictors of VTA and SCD in a period of 3-40 days following STEMI. The second objective of&#xD;
      the study is the stratification of risk for VTA by constructing optimal predictive models and&#xD;
      defining the classes of risk. The third objective of the study is a validation of the model&#xD;
      using an independent sample of patients. The study's subanalyses will include: a. Analysis of&#xD;
      the significance of non-sustained VTA lasting &lt;30 seconds for the prognosis of patients with&#xD;
      STEMI, b. Importance of frequent ventricular premature beats and/or emerging atrial&#xD;
      fibrillation for the prognosis of patients and the emergence of SCD, c. Definition of risk&#xD;
      factors for the occurrence of VTA in the subgroup of patients with preserved left ventricular&#xD;
      ejection fraction (LVEF), considering that more than half of the SCD victims have preserved&#xD;
      LVEF.&#xD;
&#xD;
      Noninvasive and invasive assessment A 24-hour ECG Holter monitoring will be performed in the&#xD;
      period of 5 ± 2 days after STEMI.&#xD;
&#xD;
      Echocardiographic examination on Vivid E9 (General Electric) echocardiographic device will be&#xD;
      performed 5 ± 2 days after STEMI and repeated after 50 ± 10 days. Standard echocardiographic&#xD;
      methods of M-mode, 2D, color, pulse, continuous doppler, tissue doppler and 2D speckle&#xD;
      tracking will be used. The analysis will include the parameters of systolic and diastolic&#xD;
      functions and myocardial mechanics in accordance with the latest recommendations of the&#xD;
      European / American Echocardiographic Association.&#xD;
&#xD;
      The following angiographic variables will be analyzed: significant coronary artery stenosis&#xD;
      -localization and number, number of diseased coronary vessels, length of stenosis, type of&#xD;
      stenosis, coronary flow before and after the intervention, type and number of implanted&#xD;
      stents.&#xD;
&#xD;
      Patients will be followed-up after discharge from hospital for the occurrence of specified&#xD;
      end points at 40 days and 1 year after enrollment by scheduled telephone interviews and&#xD;
      outpatient visits. An independent Clinical Event Committee, composed of 3 cardiologists will&#xD;
      review and adjudicate the occurrence of each suspected clinical end point.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">February 1, 2023</completion_date>
  <primary_completion_date type="Actual">October 14, 2022</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>Composite of ventricular tachyarrhythmias and sudden cardiac death</measure>
    <time_frame>3-40 days after STEMI</time_frame>
    <description>Analysis of independent predictors of ventricular tachyarrhythmias and sudden cardiac death in a period of 3-40 days following STEMI. Predictors will be identified from clinical, laboratory, echocardiographic, angiographic and procedural variables collected in the study database, using statistical methods of univariable logistic regression and Cox proportional hazard model. Statistical methods of multivariable logistic regression, bootstrapping and receiver operating characteristic curve analysis will be used for the identification of independent predictors of outcome.</description>
  </primary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Risk Stratification</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic</intervention_name>
    <description>For the analysis of myocardial function, conventional 2D echocardiography and tissue doppler will be used. For the evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical dispersion will be obtained.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 600 patients with acute myocardial infarction (AMI) with ST&#xD;
        elevation (STEMI) who are eligible for treatment with primary percutaneous coronary&#xD;
        intervention (PPCI) within 12 hours from the onset of symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  willing consent in writing&#xD;
&#xD;
          -  undergoing primary PCI for STEMI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiogenic shock at admission,&#xD;
&#xD;
          -  noncardiac conditions that could interfere with compliance with the protocol,&#xD;
&#xD;
          -  coexisting conditions associated with a limited life expectancy in the follow-up&#xD;
             period.&#xD;
&#xD;
          -  Prior documented arrhythmias like atrial fibrillation or ventricular tachyarrhythmias,&#xD;
&#xD;
          -  Permanent pacemaker implanted,&#xD;
&#xD;
          -  Previous haemodynamically significant valvular abnormalities,&#xD;
&#xD;
          -  Chest wall deformities disabling adequate echocardiographic examination.&#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>Igor Mrdovic</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Centre of Serbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Centre of Serbia, Emergency Hospital</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Centre of Serbia</investigator_affiliation>
    <investigator_full_name>Igor Mrdovic</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>risk prediction</keyword>
  <keyword>ventricular arrhythmia</keyword>
  <keyword>myocardial infarction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
    <mesh_term>Infarction</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/NCT03263949
org study id: 1533/17
nct id: NCT03263949
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Predict-VT is an investigator-initiated, prospective, observational clinical trial. Four
      hundred patients with ST elevation acute myocardial infarction (STEMI) undergoing primary
      percutaneous coronary intervention (PPCI) will be included. The primary end point is a
      composite of ventricular tachyarrhythmia (VTA) and sudden cardiac death (SCD). VTAs will be
      recorded using continuous electrocardiographic (ECG) monitoring in the coronary unit for the
      first 72 hours, standard ECG and ECG holter monitoring. For the analysis of myocardial
      function, conventional 2D echocardiography and tissue doppler will be used. For the
      evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical
      dispersion will be obtained. Important clinical, laboratory and angiographic variables will
      also be examined. Patients will be followed-up at 40 days and 1 year. The optimal VTA
      prediction model will be constructed using logistic regression and bootstrap models. Patients
      who experience primary end point should undergo secondary SCD prevention using implantable
      cardioverter defibrillator (ICD). Patients with left ventricular ejection fraction (LVEF) <
      35%, 40 days post acute myocardial infarction (AMI), will be candidates for primary SCD
      prevention.
Study design Predict-VT is an investigator-initiated, prospective, open-label, single-center
      clinical trial. The research protocol has been approved by the Ethics Committee of the
      Clinical Center of Serbia. All participants will have to provide their informed consent in
      writing. The trial design will ensure that all participants abide by good clinical practice
      and the ethical principles of the Declaration of Helsinki II.

      Study population The study will include at least 400 patients with acute myocardial
      infarction with ST elevation (STEMI) who are elgible for treatment with primary percutaneous
      coronary intervention (PPCI) within 12 hours from the onset of symptoms. Enrollment started
      on January 2017 . Recruitment will continue until 400 patients have been randomized. The end
      of the recruitment period is planned for January 2021. The trial will continue until all
      available survivors have been followed for at least 1 year.

      Objectives, end points and definitions The primary objective of PREDICT-VT trial is to test
      the hypothesis that the occurrence of ventricular tachyarrhythmias (VTA) and sudden cardiac
      death (SCD) is predictable with acceptable accuracy among STEMI patients undergoing PPCI.
      Therefore, the PREDICT-VT specified primary end point is the analysis of independent
      predictors of VTA and SCD in a period of 3-40 days following STEMI. The second objective of
      the study is the stratification of risk for VTA by constructing optimal predictive models and
      defining the classes of risk. The third objective of the study is a validation of the model
      using an independent sample of patients. The study's subanalyses will include: a. Analysis of
      the significance of non-sustained VTA lasting <30 seconds for the prognosis of patients with
      STEMI, b. Importance of frequent ventricular premature beats and/or emerging atrial
      fibrillation for the prognosis of patients and the emergence of SCD, c. Definition of risk
      factors for the occurrence of VTA in the subgroup of patients with preserved left ventricular
      ejection fraction (LVEF), considering that more than half of the SCD victims have preserved
      LVEF.

      Noninvasive and invasive assessment A 24-hour ECG Holter monitoring will be performed in the
      period of 5 ± 2 days after STEMI.

      Echocardiographic examination on Vivid E9 (General Electric) echocardiographic device will be
      performed 5 ± 2 days after STEMI and repeated after 50 ± 10 days. Standard echocardiographic
      methods of M-mode, 2D, color, pulse, continuous doppler, tissue doppler and 2D speckle
      tracking will be used. The analysis will include the parameters of systolic and diastolic
      functions and myocardial mechanics in accordance with the latest recommendations of the
      European / American Echocardiographic Association.

      The following angiographic variables will be analyzed: significant coronary artery stenosis
      -localization and number, number of diseased coronary vessels, length of stenosis, type of
      stenosis, coronary flow before and after the intervention, type and number of implanted
      stents.

      Patients will be followed-up after discharge from hospital for the occurrence of specified
      end points at 40 days and 1 year after enrollment by scheduled telephone interviews and
      outpatient visits. An independent Clinical Event Committee, composed of 3 cardiologists will
      review and adjudicate the occurrence of each suspected clinical end point.
observational model: Cohort
time perspective: Prospective
measure: Composite of ventricular tachyarrhythmias and sudden cardiac death
time frame: 3-40 days after STEMI
description: Analysis of independent predictors of ventricular tachyarrhythmias and sudden cardiac death in a period of 3-40 days following STEMI. Predictors will be identified from clinical, laboratory, echocardiographic, angiographic and procedural variables collected in the study database, using statistical methods of univariable logistic regression and Cox proportional hazard model. Statistical methods of multivariable logistic regression, bootstrapping and receiver operating characteristic curve analysis will be used for the identification of independent predictors of outcome.
intervention type: Other
intervention name: Diagnostic
description: For the analysis of myocardial function, conventional 2D echocardiography and tissue doppler will be used. For the evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical dispersion will be obtained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Igor Mrdovic
role: Principal Investigator
affiliation: Clinical Centre of Serbia
facility: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: Clinical Centre of Serbia
investigator full name: Igor Mrdovic
investigator title: Professor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
mesh term: Infarction
sharing ipd: No