<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/NCT03001284</url>
  </required_header>
  <id_info>
    <org_study_id>UMFCD-141531-RM</org_study_id>
    <nct_id>NCT03001284</nct_id>
  </id_info>
  <brief_title>Multiple Sclerosis Produces Cardiovascular Subclinical Dysfunction</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carol Davila University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carol Davila University of Medicine and Pharmacy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system,&#xD;
      may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical&#xD;
      invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed&#xD;
      mechanisms are not elucidated. The investigators aimed to assess left and right ventricular&#xD;
      (LV and RV) function, left atrial (LA) function, arterial function, and&#xD;
      atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV&#xD;
      systolic and diastolic function and RV function were assessed by 2D- and 3D-&#xD;
      echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was&#xD;
      assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by&#xD;
      intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial&#xD;
      function&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 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>Left ventricle systolic dysfunction - by echocardiography</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Right ventricle systolic dysfunction- by echocardiography</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Left ventricular diastolic function - by echocardiography</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>arterial function - by vascular echography</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple sclerosis patients</arm_group_label>
    <description>patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control subjects</arm_group_label>
    <description>control subjects, matched for age, gender, and presence of cardiovascular risk factors</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NO intervention</intervention_name>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_label>Multiple sclerosis patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        te investigators enrolled prospectively patients with confirmed multiple sclerosis,&#xD;
        diagnosed according to the revised McDonald's criteria[8], and control subjects, matched&#xD;
        for age, gender, and presence of cardiovascular risk factors.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 18 and 65 years;&#xD;
&#xD;
          2. patients with confirmed MS diagnosis, both newly diagnosed or already under&#xD;
             immunomodulatory treatment;&#xD;
&#xD;
          3. informed consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. MS treated with mitoxantrone;&#xD;
&#xD;
          2. patients with known cardiovascular disease;&#xD;
&#xD;
          3. presence of other neurological conditions;&#xD;
&#xD;
          4. any renal, pulmonary, hepatic or hematological disease;&#xD;
&#xD;
          5. diabetes mellitus;&#xD;
&#xD;
          6. any degree of arterial hypertension;&#xD;
&#xD;
          7. pregnancy;&#xD;
&#xD;
          8. and difficult acoustic window&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carol Davila University of Medicine and Pharmacy</investigator_affiliation>
    <investigator_full_name>Raluca Mincu</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT03001284
org study id: UMFCD-141531-RM
nct id: NCT03001284
lead sponsor: 
has dmc: No
Multiple sclerosis (MS), debilitating disease involving primarily the central nervous system,
      may cause cardiovascular dysfunction, due to autonomous nervous system dysfunction, physical
      invalidity, increased oxidative stress, and systemic inflammatory status, but the detailed
      mechanisms are not elucidated. The investigators aimed to assess left and right ventricular
      (LV and RV) function, left atrial (LA) function, arterial function, and
      atrial-ventricular-arterial coupling in patients with MS, compared to control subjects. LV
      systolic and diastolic function and RV function were assessed by 2D- and 3D-
      echocardiography, tissue Doppler, and speckle tracking echocardiography. LA function was
      assessed by LA volume index and LA strain. Arterial remodeling and stiffness were assessed by
      intima media-thickness, pulse wave velocity, and parameters of wave intensity and endothelial
      function
observational model: Cohort
time perspective: Prospective
measure: Left ventricle systolic dysfunction - by echocardiography
time frame: 1 year
measure: Right ventricle systolic dysfunction- by echocardiography
time frame: 1 year
measure: Left ventricular diastolic function - by echocardiography
time frame: 1 year
measure: arterial function - by vascular echography
time frame: 1 year
arm group label: Multiple sclerosis patients
description: patients with confirmed multiple sclerosis, diagnosed according to the revised McDonald's criteria
arm group label: Control subjects
description: control subjects, matched for age, gender, and presence of cardiovascular risk factors
intervention type: Other
intervention name: NO intervention
arm group label: Control subjects
arm group label: Multiple sclerosis patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Carol Davila University of Medicine and Pharmacy
investigator full name: Raluca Mincu
investigator title: Dr
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No