<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/NCT01705925</url>
  </required_header>
  <id_info>
    <org_study_id>PDX-002-11</org_study_id>
    <nct_id>NCT01705925</nct_id>
  </id_info>
  <brief_title>Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome</brief_title>
  <official_title>Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pediatrix</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pediatrix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to provide comprehensive follow-up in patients with Long QT&#xD;
      Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and&#xD;
      effective management and treatment options.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.</measure>
    <time_frame>Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Cardiac Events on patients with both phenotype and genotype positive.</measure>
    <time_frame>Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">92</enrollment>
  <condition>Long QT Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children and Young Adults with Genotype Positive Long QT Syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and/or young adults diagnosed with heterogeneous repolarization disorder who&#xD;
             have genotype positive Long QT, or&#xD;
&#xD;
          -  Newly diagnosed mutation positive patients with a confirmed test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are phenotypically positive with no molecular testing&#xD;
&#xD;
          -  Children that are phenotypically positive but genotype negative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchell Cohen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatrix</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arnold Fenrich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatrix</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reese Clark, MD</last_name>
    <role>Study Director</role>
    <affiliation>Pediatrix</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Cardiology Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>May 3, 2019</last_update_submitted>
  <last_update_submitted_qc>May 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Long QT Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT01705925
org study id: PDX-002-11
nct id: NCT01705925
lead sponsor: 
has dmc: No
The purpose of the study is to provide comprehensive follow-up in patients with Long QT
      Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and
      effective management and treatment options.
observational model: Cohort
time perspective: Prospective
measure: Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.
time frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
measure: Adverse Cardiac Events on patients with both phenotype and genotype positive.
time frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Years
healthy volunteers: No
last name: Mitchell Cohen, M.D.
role: Principal Investigator
affiliation: Pediatrix
last name: Arnold Fenrich, MD
role: Principal Investigator
affiliation: Pediatrix
last name: Reese Clark, MD
role: Study Director
affiliation: Pediatrix
facility: 
country: United States
responsible party type: Sponsor
mesh term: Long QT Syndrome
mesh term: Syndrome