xml: <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/NCT06024759</url>
    </required_header>
    <id_info>
      <org_study_id>13529</org_study_id>
      <nct_id>NCT06024759</nct_id>
    </id_info>
    <brief_title>Predictors of Risk in Left Ventricular Non-Compaction</brief_title>
    <official_title>Long Term Registry of Patients With Left Ventricular Non-Compaction and Predictors of Adverse Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lawson Health Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lawson Health Research Institute</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 goal of this study is to learn more about the risk factors associated with left&#xD;
        ventricular non-compaction (LVNC) and the predictors of adverse outcomes associated with&#xD;
        LVNC. The main questions this study aims to answer are as follows.&#xD;
  &#xD;
          -  Are there any genetic mutations that impact the risk of LVNC patients developing&#xD;
             ventricular arrhythmias?&#xD;
  &#xD;
          -  Does LV myocardial strain increase risk stratification in the LVNC population with or&#xD;
             without genetic mutations?&#xD;
  &#xD;
          -  What are some of the determinants that cause LV dysfunction in LVNC?&#xD;
  &#xD;
          -  What are other risk stratifiers (ex. premature ventricular contraction (PVC) burden on&#xD;
             Holter, non-sustained ventricular tachycardia (NSVT) on stress test) that lead to an&#xD;
             outcome of ICD implantation?&#xD;
  &#xD;
        Participants will have their medical records accessed annually for a span of ten years,&#xD;
        either prospectively or retrospectively depending on whether they are being actively followed&#xD;
        by physicians at the Inherited Arrhythmia Clinic or not, to evaluate LVNC progression over&#xD;
        time. This data will be stored in a large clinical registry with the London Heart Rhythm&#xD;
        Program at the London Health Sciences Centre, University Hospital Campus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Left ventricular noncompaction (LVNC) is a congenital cardiomyopathy in which the left&#xD;
        ventricle (LV) of the heart does not develop properly due to impaired myocardial compaction.&#xD;
        In utero, cardiac muscle is initially sponge-like, eventually becoming smooth and firm&#xD;
        through a process termed compaction. Specifically, in LVNC, impairment of compaction leads to&#xD;
        the distal portion of the LV myocardium being thicker and more sponge-like than normal.&#xD;
        Hypertrabeculation of the myocardium, where pieces of the heart muscle extend into the LV,&#xD;
        result in blood-filled trabeculae and intertrabecular recesses forming within the inner&#xD;
        endocardial wall. Collectively, this impairs the LV's ability to pump oxygenated blood&#xD;
        throughout the body.&#xD;
  &#xD;
        Although various strategies are used to manage LVNC once diagnosed, the severity of&#xD;
        comorbidities caused by LVNC, including but not limited to atrial fibrillation, embolism, or&#xD;
        stroke, warrant further investigation into the risk factors, etiology and management of LVNC.&#xD;
        Furthermore, patients with a definitive diagnosis of LVNC are at an elevated risk of&#xD;
        experiencing sudden cardiac arrest (SCA) or sudden cardiac death (SCD). However, little is&#xD;
        known about risk stratification with regards to LVNC that can result in SCA or SCD, further&#xD;
        highlighting the need for greater analysis of the risk factors implicated in this disease&#xD;
        state.&#xD;
  &#xD;
        Ultimately, a holistic understanding of the risk factors of LVNC and subsequent morbidities&#xD;
        it causes is needed to help improve the diagnosis, treatment and management of patients with&#xD;
        LVNC. Hence, the goal of this study is to evaluate the risk factors and mutations associated&#xD;
        with cardiovascular events in patients with a confirmed diagnosis of LVNC who have preserved&#xD;
        cardiac function.&#xD;
  &#xD;
        This study aims to further investigate the risk factors associated with the onset and&#xD;
        development of LVNC. Specifically, data will be collected from retrospective and prospective&#xD;
        patients. The retrospective cohort consists of patients who are no longer being actively&#xD;
        followed by physicians at the Inherited Arrhythmia Clinic at the London Health Sciences&#xD;
        Centre, University Hospital Campus, whose data will be collected annually from their medical&#xD;
        records from the past ten years. The prospective cohort consists of patients who are being&#xD;
        actively followed by physicians at the Inherited Arrhythmia Clinic who, once consented and&#xD;
        enrolled, will have their charts accessed annually for the next ten years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2033</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2033</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>10 Years</target_duration>
    <primary_outcome>
      <measure>Develop a large clinical registry linked with the Inherited Arrhythmia Clinic</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>The Inherited Arrhythmia Clinic is a subdivision of the London Heart Rhythm Program at University Hospital, London Health Sciences Centre. As such, data will not go offsite but will simply be stored in a local REDCap database.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identification of genetic mutations linked to LVNC</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Enrolled patient's will have their genetic test results thoroughly reviewed (if applicable) to better understand their involvement in the onset and progression of LVNC.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identification of determinants that cause LV dysfunction</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Enrolled patient's will have their medical charts accessed to identify factors contributing to LV dysfunction in patients with LVNC.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identification of factors that lead to ICD implantation</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Enrolled patient's will have their medical charts accessed to identify risk factors that lead to ICD implantation (if applicable) in patients with LVNC.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Left Ventricular Noncompaction</condition>
    <arm_group>
      <arm_group_label>Retrospective Cohort</arm_group_label>
      <description>Individuals in this group were previously seen by physicians at the Inherited Arrhythmia Clinic at University Hospital, London Health Sciences Centre, yet are no longer being actively followed here anymore. These patients will have their data retrospectively obtained annually, ten years into the past, to collect data on key variables providing insight on LVNC progression over time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prospective Cohort</arm_group_label>
      <description>Patients being actively followed up by physicians at the Inherited Arrhythmia Clinic will be approached either in person or via e-mail for consent and enrollment into this study. These patients will have their medical charts accessed annually to collect data on key variables providing insight on LVNC progression over time.</description>
    </arm_group>
    <biospec_retention>None Retained</biospec_retention>
    <biospec_descr>
      <textblock>
        Genetic testing&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients in this study have a confirmed diagnosis of LVNC. Specifically, those in the&#xD;
          prospective cohort are being actively followed up by physicians at the Inherited Arrhythmia&#xD;
          Clinic whereas those in the retrospective cohort are no longer being actively followed up.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          Patients must meet the following criteria in order to be included in the study.&#xD;
  &#xD;
            -  Have a confirmed diagnosis of LVNC (between 2010-2020 for patients in the&#xD;
               retrospective cohort only)&#xD;
  &#xD;
            -  Be over 18 years of age&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          Patients are ineligible to participate in this study if they do not meet one or more of the&#xD;
          inclusion criterion or if they have any other cardiomyopathy aside from LVNC that is linked&#xD;
          to a genetic mutation they carry.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>LVNC</keyword>
    <keyword>Left Ventricular Non-Compaction</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024759
  org study id: 13529
  nct id: NCT06024759
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to learn more about the risk factors associated with left
        ventricular non-compaction (LVNC) and the predictors of adverse outcomes associated with
        LVNC. The main questions this study aims to answer are as follows.
  
          -  Are there any genetic mutations that impact the risk of LVNC patients developing
             ventricular arrhythmias?
  
          -  Does LV myocardial strain increase risk stratification in the LVNC population with or
             without genetic mutations?
  
          -  What are some of the determinants that cause LV dysfunction in LVNC?
  
          -  What are other risk stratifiers (ex. premature ventricular contraction (PVC) burden on
             Holter, non-sustained ventricular tachycardia (NSVT) on stress test) that lead to an
             outcome of ICD implantation?
  
        Participants will have their medical records accessed annually for a span of ten years,
        either prospectively or retrospectively depending on whether they are being actively followed
        by physicians at the Inherited Arrhythmia Clinic or not, to evaluate LVNC progression over
        time. This data will be stored in a large clinical registry with the London Heart Rhythm
        Program at the London Health Sciences Centre, University Hospital Campus.
  Left ventricular noncompaction (LVNC) is a congenital cardiomyopathy in which the left
        ventricle (LV) of the heart does not develop properly due to impaired myocardial compaction.
        In utero, cardiac muscle is initially sponge-like, eventually becoming smooth and firm
        through a process termed compaction. Specifically, in LVNC, impairment of compaction leads to
        the distal portion of the LV myocardium being thicker and more sponge-like than normal.
        Hypertrabeculation of the myocardium, where pieces of the heart muscle extend into the LV,
        result in blood-filled trabeculae and intertrabecular recesses forming within the inner
        endocardial wall. Collectively, this impairs the LV's ability to pump oxygenated blood
        throughout the body.
  
        Although various strategies are used to manage LVNC once diagnosed, the severity of
        comorbidities caused by LVNC, including but not limited to atrial fibrillation, embolism, or
        stroke, warrant further investigation into the risk factors, etiology and management of LVNC.
        Furthermore, patients with a definitive diagnosis of LVNC are at an elevated risk of
        experiencing sudden cardiac arrest (SCA) or sudden cardiac death (SCD). However, little is
        known about risk stratification with regards to LVNC that can result in SCA or SCD, further
        highlighting the need for greater analysis of the risk factors implicated in this disease
        state.
  
        Ultimately, a holistic understanding of the risk factors of LVNC and subsequent morbidities
        it causes is needed to help improve the diagnosis, treatment and management of patients with
        LVNC. Hence, the goal of this study is to evaluate the risk factors and mutations associated
        with cardiovascular events in patients with a confirmed diagnosis of LVNC who have preserved
        cardiac function.
  
        This study aims to further investigate the risk factors associated with the onset and
        development of LVNC. Specifically, data will be collected from retrospective and prospective
        patients. The retrospective cohort consists of patients who are no longer being actively
        followed by physicians at the Inherited Arrhythmia Clinic at the London Health Sciences
        Centre, University Hospital Campus, whose data will be collected annually from their medical
        records from the past ten years. The prospective cohort consists of patients who are being
        actively followed by physicians at the Inherited Arrhythmia Clinic who, once consented and
        enrolled, will have their charts accessed annually for the next ten years.
  observational model: Case-Only
  time perspective: Other
  measure: Develop a large clinical registry linked with the Inherited Arrhythmia Clinic
  time frame: Up to 10 years
  description: The Inherited Arrhythmia Clinic is a subdivision of the London Heart Rhythm Program at University Hospital, London Health Sciences Centre. As such, data will not go offsite but will simply be stored in a local REDCap database.
  measure: Identification of genetic mutations linked to LVNC
  time frame: Up to 10 years
  description: Enrolled patient's will have their genetic test results thoroughly reviewed (if applicable) to better understand their involvement in the onset and progression of LVNC.
  measure: Identification of determinants that cause LV dysfunction
  time frame: Up to 10 years
  description: Enrolled patient's will have their medical charts accessed to identify factors contributing to LV dysfunction in patients with LVNC.
  measure: Identification of factors that lead to ICD implantation
  time frame: Up to 10 years
  description: Enrolled patient's will have their medical charts accessed to identify risk factors that lead to ICD implantation (if applicable) in patients with LVNC.
  arm group label: Retrospective Cohort
  description: Individuals in this group were previously seen by physicians at the Inherited Arrhythmia Clinic at University Hospital, London Health Sciences Centre, yet are no longer being actively followed here anymore. These patients will have their data retrospectively obtained annually, ten years into the past, to collect data on key variables providing insight on LVNC progression over time.
  arm group label: Prospective Cohort
  description: Patients being actively followed up by physicians at the Inherited Arrhythmia Clinic will be approached either in person or via e-mail for consent and enrollment into this study. These patients will have their medical charts accessed annually to collect data on key variables providing insight on LVNC progression over time.
  Genetic testing
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  responsible party type: Sponsor