<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/NCT04490538</url>
  </required_header>
  <id_info>
    <org_study_id>284/34</org_study_id>
    <nct_id>NCT04490538</nct_id>
  </id_info>
  <brief_title>Evaluation of Right Ventricular Systolic Function by TAPSE Parameter From Subcostal View</brief_title>
  <official_title>Echocardiographic Evaluation of Right Ventricular Systolic Function by TAPSE Parameter Measured From Subcostal View Using Anatomical M-mode - Validation Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emergency Medical Service of the Central Bohemian Region, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masaryk Hospital Usti nad Labem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Service of the Central Bohemian Region, Czech Republic</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 purpose of this study is to validate a new echocardiographic parameter evaluating right&#xD;
      ventricular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The key conventional echocardiographic parameter evaluating right ventricular systolic&#xD;
      function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical&#xD;
      four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right&#xD;
      ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic&#xD;
      Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four&#xD;
      chamber view as well. However, this view might not be clearly visible in the clinical setting&#xD;
      of critical illness and subcostal view is often preferred for its higher quality.&#xD;
      Unfortunately, conventional M-mode can not be used for measurement in this view but&#xD;
      anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE&#xD;
      measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE&#xD;
      and whether reliably reflects systolic right ventricular function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of sTAPSE in prediction of right ventricular systolic dysfunction</measure>
    <time_frame>During the intervention</time_frame>
    <description>sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of sTAPSE with conventional TAPSE</measure>
    <time_frame>During the intervention</time_frame>
    <description>sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Transthoracic Echocardiography</condition>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>Critically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transthoracic echocardiography</intervention_name>
    <description>Conventional transthoracic echocardiographic examination at the intensive care unit.</description>
    <arm_group_label>Critically ill patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult intensive care unit patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients&#xD;
&#xD;
          -  All patients hospitalised in intensive care unit indicated for transthoracic&#xD;
             echocardiography examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Insufficient imaging quality of transthoracic echocardiography&#xD;
&#xD;
          -  Refusal of echocardiographic examination by patient&#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_official>
    <last_name>Roman Skulec, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masaryk Hospital Usti nad Labem</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roman Skulec, MD, PhD</last_name>
    <phone>00420777577497</phone>
    <email>skulec@email.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tomas Parizek, MD</last_name>
    <phone>00420603187997</phone>
    <email>parizek.t1@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Masaryk Hospital Usti nad Labem</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>40113</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roman Skulec, MD, PhD</last_name>
      <phone>00420777577497</phone>
      <email>skulec@email.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Erratum In: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969.</citation>
    <PMID>25712077</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Masaryk Hospital Usti nad Labem</investigator_affiliation>
    <investigator_full_name>Roman Skulec</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Systolic Murmurs</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/NCT04490538
org study id: 284/34
nct id: NCT04490538
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to validate a new echocardiographic parameter evaluating right
      ventricular function.
The key conventional echocardiographic parameter evaluating right ventricular systolic
      function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical
      four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right
      ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic
      Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four
      chamber view as well. However, this view might not be clearly visible in the clinical setting
      of critical illness and subcostal view is often preferred for its higher quality.
      Unfortunately, conventional M-mode can not be used for measurement in this view but
      anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE
      measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE
      and whether reliably reflects systolic right ventricular function.
observational model: Case-Only
time perspective: Prospective
measure: Validity of sTAPSE in prediction of right ventricular systolic dysfunction
time frame: During the intervention
description: sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.
measure: Correlation of sTAPSE with conventional TAPSE
time frame: During the intervention
description: sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.
arm group label: Critically ill patients
description: Critically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination.
intervention type: Diagnostic Test
intervention name: Transthoracic echocardiography
description: Conventional transthoracic echocardiographic examination at the intensive care unit.
arm group label: Critically ill patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roman Skulec, MD, PhD
role: Principal Investigator
affiliation: Masaryk Hospital Usti nad Labem
last name: Roman Skulec, MD, PhD
phone: 00420777577497
email: skulec@email.cz
last name: Tomas Parizek, MD
phone: 00420603187997
email: parizek.t1@gmail.com
facility: 
status: Recruiting
contact: 
country: Czechia
citation: Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Erratum In: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969.
PMID: 25712077
responsible party type: Principal Investigator
investigator affiliation: Masaryk Hospital Usti nad Labem
investigator full name: Roman Skulec
investigator title: Principal investigator
mesh term: Systolic Murmurs
sharing ipd: No