<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/NCT04442828</url>
  </required_header>
  <id_info>
    <org_study_id>106848</org_study_id>
    <nct_id>NCT04442828</nct_id>
  </id_info>
  <brief_title>3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation</brief_title>
  <acronym>3D-PRIME</acronym>
  <official_title>3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</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 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk&#xD;
      stratification and cardiovascular outcome in patients with mitral regurgitation of different&#xD;
      etiologies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 17, 2020</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">April 2025</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>Major cardiovascular event</measure>
    <time_frame>24 months</time_frame>
    <description>Death, mitral valve intervention, heart failure hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mitral valve intervention</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>Primary mitral regurgitation</arm_group_label>
    <description>Patients with mitral regurgitation due to mitral valve disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary mitral regurgitation</arm_group_label>
    <description>Patients with mitral regurgitation due to ventricular or atrial disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Use of 3D echocardiography in patient follow-up</intervention_name>
    <description>Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.</description>
    <arm_group_label>Primary mitral regurgitation</arm_group_label>
    <arm_group_label>Secondary mitral regurgitation</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Proteomics, metabolomics&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A cohort of patients with chronic mitral regurgitation referred for clinical and&#xD;
        echocardiographic assessment at the Heart Valve Clinic at Haukeland University Hospital in&#xD;
        Bergen, Norway.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients with primary or secondary mitral regurgitation of mild, moderate or severe&#xD;
        degree. 3D echocardiographic examinations of &gt;= good resolution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Co-existence of another valve disease of severe degree, inability to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dana Cramariuc, MD PhD</last_name>
    <phone>+4755976755</phone>
    <email>cdan@helse-bergen.no</email>
  </overall_contact>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dana Cramariuc, MD PhD</last_name>
      <phone>+4755970534</phone>
      <email>cdan@helse-bergen.no</email>
    </contact>
    <investigator>
      <last_name>Dana Cramariuc, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</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>Mitral Valve Insufficiency</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/NCT04442828
org study id: 106848
nct id: NCT04442828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk
      stratification and cardiovascular outcome in patients with mitral regurgitation of different
      etiologies.
observational model: Cohort
time perspective: Prospective
measure: Major cardiovascular event
time frame: 24 months
description: Death, mitral valve intervention, heart failure hospitalization
measure: All-cause death
time frame: 24 months
measure: Cardiovascular death
time frame: 24 months
measure: Mitral valve intervention
time frame: 24 months
arm group label: Primary mitral regurgitation
description: Patients with mitral regurgitation due to mitral valve disease
arm group label: Secondary mitral regurgitation
description: Patients with mitral regurgitation due to ventricular or atrial disease
intervention type: Diagnostic Test
intervention name: Use of 3D echocardiography in patient follow-up
description: Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.
arm group label: Primary mitral regurgitation
arm group label: Secondary mitral regurgitation
Proteomics, metabolomics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dana Cramariuc, MD PhD
phone: +4755976755
email: cdan@helse-bergen.no
facility: 
status: Recruiting
contact: 
investigator: 
country: Norway
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No