<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/NCT03783975</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00081981</org_study_id>
    <secondary_id>R21HG010412</secondary_id>
    <nct_id>NCT03783975</nct_id>
  </id_info>
  <brief_title>KCNQ1 Cascade Screening</brief_title>
  <official_title>A Community-Based Approach to Overcoming Barriers to Cascade Screening for Long QT Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Human Genome Research Institute (NHGRI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</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 objectives of the protocol are to: (1) evaluate the uptake of cascade screening and&#xD;
      preventative therapies after the implementation of a simplified screening process and (2)&#xD;
      assess proband and family member perspectives about the return of research results and&#xD;
      cascade screening for the KCNQ1 Thr224Met variant. The investigators will conduct a mixed&#xD;
      methods study in the Old Order Amish community where the KCNQ1 variant is enriched over&#xD;
      100,000-fold compared to other populations. The intervention will offer free, mail-in,&#xD;
      saliva-based genetic testing for family members of probands. The rate of uptake of testing&#xD;
      and preventative therapy after the intervention is implemented (i.e. when 'simplified' free,&#xD;
      mail-in, saliva-based testing was available) will be compared to data from before the&#xD;
      intervention (i.e. when 'traditional' $50 blood-based testing was available to family&#xD;
      members) when uptake was essentially zero. The primary outcome is the rate of uptake of&#xD;
      cascade screening with the intervention ('simplified'). The secondary outcomes include:&#xD;
      extent of disclosure of genotype results before and after the intervention, proportion of&#xD;
      informed relatives who get screened before and after the intervention, and the uptake of&#xD;
      appropriate preventative care (e.g. seeing a cardiologist and/or taking beta-blocker). The&#xD;
      tertiary outcomes are demographic characteristics associated with uptake of cascade screening&#xD;
      or uptake of preventative therapy. The investigators will also assess qualitative themes&#xD;
      surrounding the return of results process and cascade screening using interviews.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to obtain all survey data due to COVID delay&#xD;
  </why_stopped>
  <start_date type="Actual">March 7, 2019</start_date>
  <completion_date type="Actual">December 29, 2022</completion_date>
  <primary_completion_date type="Actual">April 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of At-risk Family Members Who Underwent Cascade Screening</measure>
    <time_frame>18 months</time_frame>
    <description>Rate of uptake of cascade screening after the intervention ('simplified')</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extent of Disclosure Determined by Questionnaire</measure>
    <time_frame>18 months</time_frame>
    <description>proportion of family members told after the intervention ('simplified')</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Informed Relatives Screened Determined by Questionnaire</measure>
    <time_frame>18 months</time_frame>
    <description>Number of informed family members tested after the intervention ('simplified')</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Uptake of Preventative Therapy as Determined by Questionnaire</measure>
    <time_frame>18 months</time_frame>
    <description>Uptake of preventative therapy was defined as those taking a beta-blocker if recommended or those who implemented lifestyle modifications if beta-blocker not recommended. The survey was mailed to all probands.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Long QT Syndrome</condition>
  <arm_group>
    <arm_group_label>Simplified Cascade Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Simplified Cascade Screening</intervention_name>
    <description>Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
    <arm_group_label>Simplified Cascade Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  KCNQ1Thr224Met proband or first degree family member&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family members who have not been contacted by probands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Maryland Amish Research Clinic</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>September 30, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 26, 2022</results_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Amber Beitelshees</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cascade</keyword>
  <keyword>Screening</keyword>
  <keyword>Ethical</keyword>
  <keyword>Legal</keyword>
  <keyword>Social</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 14, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03783975/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Simplified Cascade Screening</title>
          <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Simplified Cascade Screening</title>
          <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="131"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of At-risk Family Members Who Underwent Cascade Screening</title>
        <description>Rate of uptake of cascade screening after the intervention ('simplified')</description>
        <time_frame>18 months</time_frame>
        <population>809 family members were eligible to be screened and were considered at-risk.</population>
        <group_list>
          <group group_id="O1">
            <title>Simplified Cascade Screening</title>
            <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of At-risk Family Members Who Underwent Cascade Screening</title>
          <description>Rate of uptake of cascade screening after the intervention ('simplified')</description>
          <population>809 family members were eligible to be screened and were considered at-risk.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="809"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Extent of Disclosure Determined by Questionnaire</title>
        <description>proportion of family members told after the intervention ('simplified')</description>
        <time_frame>18 months</time_frame>
        <population>Because of COVID, too much time had passed since we had originally contacted the probands and we did not think we could get reliable data on how many family members they had told after the intervention. Thus, these data were not collected. During the COVID pandemic we had to switch gears and warn people with LQTS about the risks of QT-prolongation with chloroquine, hydroxychloroquine, and azithromycin.</population>
        <group_list>
          <group group_id="O1">
            <title>Simplified Cascade Screening</title>
            <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
          </group>
        </group_list>
        <measure>
          <title>Extent of Disclosure Determined by Questionnaire</title>
          <description>proportion of family members told after the intervention ('simplified')</description>
          <population>Because of COVID, too much time had passed since we had originally contacted the probands and we did not think we could get reliable data on how many family members they had told after the intervention. Thus, these data were not collected. During the COVID pandemic we had to switch gears and warn people with LQTS about the risks of QT-prolongation with chloroquine, hydroxychloroquine, and azithromycin.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Informed Relatives Screened Determined by Questionnaire</title>
        <description>Number of informed family members tested after the intervention ('simplified')</description>
        <time_frame>18 months</time_frame>
        <population>Number of family members tested of those mailed letters. The overall number of participants analyzed differs from the number in the Participant Flow Module because it represents the number of family members who were mailed letters whereas the participant flow module includes individuals who consented for testing. These numbers are not related to each other because we didn't mail letters to children, although children were eligible for testing.</population>
        <group_list>
          <group group_id="O1">
            <title>Simplified Cascade Screening</title>
            <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Informed Relatives Screened Determined by Questionnaire</title>
          <description>Number of informed family members tested after the intervention ('simplified')</description>
          <population>Number of family members tested of those mailed letters. The overall number of participants analyzed differs from the number in the Participant Flow Module because it represents the number of family members who were mailed letters whereas the participant flow module includes individuals who consented for testing. These numbers are not related to each other because we didn't mail letters to children, although children were eligible for testing.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Uptake of Preventative Therapy as Determined by Questionnaire</title>
        <description>Uptake of preventative therapy was defined as those taking a beta-blocker if recommended or those who implemented lifestyle modifications if beta-blocker not recommended. The survey was mailed to all probands.</description>
        <time_frame>18 months</time_frame>
        <population>We analyzed the number of survey responses obtained for the questions on beta-blocker therapy and lifestyle modifications which is why the numbers are different than those reported in the participant flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>Simplified Cascade Screening</title>
            <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Uptake of Preventative Therapy as Determined by Questionnaire</title>
          <description>Uptake of preventative therapy was defined as those taking a beta-blocker if recommended or those who implemented lifestyle modifications if beta-blocker not recommended. The survey was mailed to all probands.</description>
          <population>We analyzed the number of survey responses obtained for the questions on beta-blocker therapy and lifestyle modifications which is why the numbers are different than those reported in the participant flow module.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were obtained at the time of saliva sample collection.</time_frame>
      <desc>Adverse events were obtained at the time of enrollment when saliva samples were collected. All other study procedures were surveys.</desc>
      <group_list>
        <group group_id="E1">
          <title>Simplified Cascade Screening</title>
          <description>Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.&#xD;
Simplified Cascade Screening: Screening of the KCNQ1 Thr224Met variant for family members of probands</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Amber Beitelshees</name_or_title>
      <organization>University of Maryland Baltimore</organization>
      <phone>410-706-0118</phone>
      <email>abeitels@som.umaryland.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03783975
org study id: HP-00081981
secondary id: R21HG010412
nct id: NCT03783975
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of the protocol are to: (1) evaluate the uptake of cascade screening and
      preventative therapies after the implementation of a simplified screening process and (2)
      assess proband and family member perspectives about the return of research results and
      cascade screening for the KCNQ1 Thr224Met variant. The investigators will conduct a mixed
      methods study in the Old Order Amish community where the KCNQ1 variant is enriched over
      100,000-fold compared to other populations. The intervention will offer free, mail-in,
      saliva-based genetic testing for family members of probands. The rate of uptake of testing
      and preventative therapy after the intervention is implemented (i.e. when 'simplified' free,
      mail-in, saliva-based testing was available) will be compared to data from before the
      intervention (i.e. when 'traditional' $50 blood-based testing was available to family
      members) when uptake was essentially zero. The primary outcome is the rate of uptake of
      cascade screening with the intervention ('simplified'). The secondary outcomes include:
      extent of disclosure of genotype results before and after the intervention, proportion of
      informed relatives who get screened before and after the intervention, and the uptake of
      appropriate preventative care (e.g. seeing a cardiologist and/or taking beta-blocker). The
      tertiary outcomes are demographic characteristics associated with uptake of cascade screening
      or uptake of preventative therapy. The investigators will also assess qualitative themes
      surrounding the return of results process and cascade screening using interviews.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Percentage of At-risk Family Members Who Underwent Cascade Screening
time frame: 18 months
description: Rate of uptake of cascade screening after the intervention ('simplified')
measure: Extent of Disclosure Determined by Questionnaire
time frame: 18 months
description: proportion of family members told after the intervention ('simplified')
measure: Number of Informed Relatives Screened Determined by Questionnaire
time frame: 18 months
description: Number of informed family members tested after the intervention ('simplified')
measure: Number of Participants With an Uptake of Preventative Therapy as Determined by Questionnaire
time frame: 18 months
description: Uptake of preventative therapy was defined as those taking a beta-blocker if recommended or those who implemented lifestyle modifications if beta-blocker not recommended. The survey was mailed to all probands.
arm group label: Simplified Cascade Screening
arm group type: Experimental
description: Free, mail-in, saliva-based screening for the KCNQ1 Thr224Met variant.
intervention type: Genetic
intervention name: Simplified Cascade Screening
description: Screening of the KCNQ1 Thr224Met variant for family members of probands
arm group label: Simplified Cascade Screening
criteria: 
gender: All
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Amber Beitelshees
investigator title: Assistant Professor
mesh term: Long QT Syndrome
mesh term: Syndrome
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 