<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/NCT01678274</url>
  </required_header>
  <id_info>
    <org_study_id>35202</org_study_id>
    <nct_id>NCT01678274</nct_id>
  </id_info>
  <brief_title>Prospective Characterization of the Heart, Aorta and Blood Pressure in Turner Syndrome. Association With Aortic Dissection.</brief_title>
  <acronym>TSCORII</acronym>
  <official_title>Prospective Characterization of the Heart, Aorta and Blood Pressure in Women With Turner Syndrome. Association With Aortic Dissection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes&#xD;
      affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence&#xD;
      of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and&#xD;
      autoimmune diseases in general.&#xD;
&#xD;
      Our study aim is:&#xD;
&#xD;
        -  Using MRI to further characterize and find risk factors leading to aortic dilation.&#xD;
&#xD;
        -  Using MRI to assess the degree of aortic distensibility.&#xD;
&#xD;
        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to&#xD;
           characterize the prevalence and degree of ischemic heart disease and coronary anomalies.&#xD;
&#xD;
        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of&#xD;
           aortic stiffness when compared to controls using end points as Pulse Wave Velocity,&#xD;
           Augmentation Index and Central Pulse Pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes&#xD;
      affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence&#xD;
      of ischemic heart disease, aortic dilation and dissection, congenital heart defects,&#xD;
      hypertension, stroke, ovarian failure, infertility, decreased final height and autoimmune&#xD;
      diseases in general&#xD;
&#xD;
      Our study aim is:&#xD;
&#xD;
        -  Using MRI to further characterize and find risk factors leading to aortic dilation.&#xD;
&#xD;
        -  Using MRI to describe aortic dimensions&#xD;
&#xD;
        -  Using MRI to assess the degree of aortic distensibility.&#xD;
&#xD;
        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to&#xD;
           characterize the prevalence and degree of ischemic heart disease and coronary anomalies.&#xD;
&#xD;
        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of&#xD;
           aortic stiffness when compared to controls using end points as Pulse Wave Velocity,&#xD;
           Augmentation Index and Central Pulse Pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Aortic dimensions</measure>
    <time_frame>Once</time_frame>
    <description>Aortic dimensions measured by MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Agatston score</measure>
    <time_frame>Once</time_frame>
    <description>Coronary CT evaluation of Agatston score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Segment involvement score</measure>
    <time_frame>Once</time_frame>
    <description>Segment involvement score (SIS) calculated as the sum of segments with one or more coronary plaques (score 0-18).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aortic distensibility</measure>
    <time_frame>Once</time_frame>
    <description>Aortic distensibillity as measured by MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24 hour blood pressure</measure>
    <time_frame>24 hour</time_frame>
    <description>24 hour blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse Wave Velocity</measure>
    <time_frame>Once</time_frame>
    <description>Pulse Wave Velocity measured by applanation tonometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Augmentation index</measure>
    <time_frame>Once</time_frame>
    <description>Augmentation index measured by applanation tonometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central blood pressure</measure>
    <time_frame>Once</time_frame>
    <description>Central blood pressure measured by applanation tonometry.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>echocardiography</measure>
    <time_frame>Once</time_frame>
    <description>echocardiography evaluating Mitral and aortic valves, left ventricular hypertrophy, diastolic and systolic function etc..</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Turner Syndrome</condition>
  <condition>Aortic Aneurysm</condition>
  <condition>Ischemic Heart Disease</condition>
  <condition>Hypertension</condition>
  <condition>Congenital Heart Defect</condition>
  <arm_group>
    <arm_group_label>Turner syndrome</arm_group_label>
    <description>Females with Turner syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>age matched females acting as controls</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Females with Turner Syndrome previously participating in our study number 2001024 are&#xD;
        recruited from out-patient clinics.&#xD;
&#xD;
        Controls are healthy volunteers recruited from the general population by advertisement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria with respect to individuals acting as controls:&#xD;
&#xD;
          -  Healthy age matched females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for MRI&#xD;
&#xD;
          -  Contraindications for CT&#xD;
&#xD;
          -  Severe obesity&#xD;
&#xD;
          -  Acute og Chronic disease with known or presumed significance with concern to outcomes&#xD;
             of the study&#xD;
&#xD;
          -  Previous or present malignant disease&#xD;
&#xD;
          -  Clinically significant liver disease&#xD;
&#xD;
          -  Mechanic or biological heart valves&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claus H Gravholt, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Trolle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Endocrinology and Internal medicine</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>May 23, 2016</last_update_submitted>
  <last_update_submitted_qc>May 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Turner Syndrome</keyword>
  <keyword>Aortic Aneurysm</keyword>
  <keyword>Ischemic heart disease</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Congenital Heart Defect</keyword>
  <keyword>Pulse Wave Velocity</keyword>
  <keyword>Augmentation Index</keyword>
  <keyword>Central Blood Pressure</keyword>
  <keyword>Agatston Score</keyword>
  <keyword>Segment involvement score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Turner Syndrome</mesh_term>
    <mesh_term>Gonadal Dysgenesis</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT01678274
org study id: 35202
nct id: NCT01678274
lead sponsor: 
has dmc: No
Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes
      affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence
      of ischemic heart disease, aortic dilation and dissection, hypertension, stroke and
      autoimmune diseases in general.

      Our study aim is:

        -  Using MRI to further characterize and find risk factors leading to aortic dilation.

        -  Using MRI to assess the degree of aortic distensibility.

        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to
           characterize the prevalence and degree of ischemic heart disease and coronary anomalies.

        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of
           aortic stiffness when compared to controls using end points as Pulse Wave Velocity,
           Augmentation Index and Central Pulse Pressure.
Turner syndrome is a congenital complete or partial lack one of the female sex chromosomes
      affecting 1 of 2000 live born girls. The syndrome is characterized by an increased prevalence
      of ischemic heart disease, aortic dilation and dissection, congenital heart defects,
      hypertension, stroke, ovarian failure, infertility, decreased final height and autoimmune
      diseases in general

      Our study aim is:

        -  Using MRI to further characterize and find risk factors leading to aortic dilation.

        -  Using MRI to describe aortic dimensions

        -  Using MRI to assess the degree of aortic distensibility.

        -  Using Computed tomography x-ray scanning of the heart and coronary arteries to
           characterize the prevalence and degree of ischemic heart disease and coronary anomalies.

        -  Using pressure sensitive ultrasound (applanation tonometry) to assess the degree of
           aortic stiffness when compared to controls using end points as Pulse Wave Velocity,
           Augmentation Index and Central Pulse Pressure.
observational model: Cohort
time perspective: Prospective
measure: Aortic dimensions
time frame: Once
description: Aortic dimensions measured by MRI
measure: Agatston score
time frame: Once
description: Coronary CT evaluation of Agatston score
measure: Segment involvement score
time frame: Once
description: Segment involvement score (SIS) calculated as the sum of segments with one or more coronary plaques (score 0-18).
measure: Aortic distensibility
time frame: Once
description: Aortic distensibillity as measured by MRI
measure: 24 hour blood pressure
time frame: 24 hour
description: 24 hour blood pressure
measure: Pulse Wave Velocity
time frame: Once
description: Pulse Wave Velocity measured by applanation tonometry.
measure: Augmentation index
time frame: Once
description: Augmentation index measured by applanation tonometry.
measure: Central blood pressure
time frame: Once
description: Central blood pressure measured by applanation tonometry.
measure: echocardiography
time frame: Once
description: echocardiography evaluating Mitral and aortic valves, left ventricular hypertrophy, diastolic and systolic function etc..
arm group label: Turner syndrome
description: Females with Turner syndrome
arm group label: Control group
description: age matched females acting as controls
Blood Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claus H Gravholt, MD
role: Study Chair
affiliation: Aarhus University Hospital
last name: Christian Trolle, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Turner Syndrome
mesh term: Gonadal Dysgenesis
mesh term: Hypertension
mesh term: Heart Diseases
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Aortic Dissection
mesh term: Heart Defects, Congenital
mesh term: Syndrome