<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/NCT03784586</url>
  </required_header>
  <id_info>
    <org_study_id>01_MD1</org_study_id>
    <nct_id>NCT03784586</nct_id>
  </id_info>
  <brief_title>Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients</brief_title>
  <acronym>ACADEMY 1</acronym>
  <official_title>The Electrophysiological Study Guided ICD Strategy in Prevention of Arrhythmic Cardiac Death in Myotonic Dystrophy Type 1 Patients With Conduction System Disease (ACADEMY 1 Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</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 aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy,&#xD;
      including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in&#xD;
      inducible patients, is able to improve survival in comparison with conventional therapy (CONV&#xD;
      strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial design:&#xD;
&#xD;
      This is a double-arm prospective observational study.&#xD;
&#xD;
      Patient population:&#xD;
&#xD;
      To be included in the study, DM1 patients had to have at least 18 years old, LVEF &gt;35% on&#xD;
      two-dimensional echocardiography, permanent pacing indication after non-invasive&#xD;
      electrocardiographic evaluation or invasive EPS evaluation, according to the current&#xD;
      guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid&#xD;
      disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained&#xD;
      ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect&#xD;
      cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular&#xD;
      stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent&#xD;
      subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and&#xD;
      underwent pacemaker implantation.&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
      The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD),&#xD;
      death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sudden Cardiac Death</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Myotonic Dystrophy 1</condition>
  <condition>Sudden Cardiac Death</condition>
  <arm_group>
    <arm_group_label>Positive EPS - ICD</arm_group_label>
    <description>Patients with inducible sustained ventricular tachycardia or ventricular fibrillation at EPS evaluation underwent ICD implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative EPS - PMK</arm_group_label>
    <description>All non inducible patients underwent PMK implantation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        MD1 patients with permanent pacing indication and needed of sudden cardiac death screening.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MD1 diagnosis genetically confirmed&#xD;
&#xD;
          -  LVEF &gt;35% on two-dimensional echocardiography&#xD;
&#xD;
          -  Permanent pacing indication according to the current guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electrolyte imbalance&#xD;
&#xD;
          -  Thyroid disorders&#xD;
&#xD;
          -  Prior cardiac surgery&#xD;
&#xD;
          -  Prior cardiac arrest&#xD;
&#xD;
          -  Prior spontaneous sustained ventricular arrhythmias&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vincenzo Russo, MD,PhD</last_name>
    <phone>0817064149</phone>
    <email>v.p.russo@libero.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Antonio Papa, MD</last_name>
    <phone>0817065158</phone>
    <email>andreaantoniopapa@libero.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vincenzo Russo</name>
      <address>
        <city>Naples</city>
        <zip>80136</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 13, 2021</last_update_submitted>
  <last_update_submitted_qc>June 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Vincenzo Russo</investigator_full_name>
    <investigator_title>MD, PhD, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Arrhythmias</keyword>
  <keyword>electrophisiological study</keyword>
  <keyword>primary prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myotonic Dystrophy</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Death</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/NCT03784586
org study id: 01_MD1
nct id: NCT03784586
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy,
      including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in
      inducible patients, is able to improve survival in comparison with conventional therapy (CONV
      strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.
Trial design:

      This is a double-arm prospective observational study.

      Patient population:

      To be included in the study, DM1 patients had to have at least 18 years old, LVEF >35% on
      two-dimensional echocardiography, permanent pacing indication after non-invasive
      electrocardiographic evaluation or invasive EPS evaluation, according to the current
      guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid
      disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained
      ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect
      cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular
      stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent
      subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and
      underwent pacemaker implantation.

      Endpoints:

      The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD),
      death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted
      patients.
observational model: Case-Control
time perspective: Prospective
measure: Sudden Cardiac Death
time frame: 24 months
measure: All-cause mortality
time frame: 24 months
arm group label: Positive EPS - ICD
description: Patients with inducible sustained ventricular tachycardia or ventricular fibrillation at EPS evaluation underwent ICD implantation
arm group label: Negative EPS - PMK
description: All non inducible patients underwent PMK implantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Vincenzo Russo, MD,PhD
phone: 0817064149
email: v.p.russo@libero.it
last name: Andrea Antonio Papa, MD
phone: 0817065158
email: andreaantoniopapa@libero.it
facility: 
status: Recruiting
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Vincenzo Russo
investigator title: MD, PhD, Assistant Professor
mesh term: Myotonic Dystrophy
mesh term: Death, Sudden, Cardiac
mesh term: Death
sharing ipd: No