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/NCT05980533</url>
    </required_header>
    <id_info>
      <org_study_id>2307-41</org_study_id>
      <nct_id>NCT05980533</nct_id>
    </id_info>
    <brief_title>Portable Ultrasound to Predict Heart Failure Readmission Risk</brief_title>
    <official_title>Utility and Feasibility of Prehospital Portable Ultrasound to Predict Heart Failure Readmission Risk</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Guthrie Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Guthrie Clinic</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 research is to use a handheld ultrasound to assess patients with&#xD;
        congestive heart failure (CHF) to see if the ultrasound can help predict readmission to the&#xD;
        hospital. The study will include patients who are admitted to the hospital for CHF.&#xD;
        Participants will have two ultrasounds at hospital discharge and at a follow up visit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this research is to see if a portable ultrasound can help predict readmission&#xD;
        to the hospital for patients who are admitted to the hospital for CHF. The study will enroll&#xD;
        patients who take part in Mobile Integrated Healthcare as part of their routine care.&#xD;
        Participants will have two ultrasounds. The first ultrasound will be at hospital discharge.&#xD;
  &#xD;
        Between seven to ten days after hospital discharge participants will be visited at their home&#xD;
        in follow-up as the usual standard of care for Mobile Integrated Healthcare. At this visit&#xD;
        participants will have a second ultrasound. Participants will be followed for one year for&#xD;
        hospital readmission.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hospital Readmission</measure>
      <time_frame>30 days</time_frame>
      <description>Hospital readmission within 30 days of discharge</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Heart Failure</condition>
    <condition>Patient Readmission</condition>
    <arm_group>
      <arm_group_label>Ultrasound</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ultrasound at hospital discharge and at follow up in 7-10 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>Ultrasound at hospital discharge and at follow up at 7-10 days</description>
      <arm_group_label>Ultrasound</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary admission diagnosis is listed as congestive heart failure, with an acute&#xD;
               component of decompensation.&#xD;
  &#xD;
            -  Age greater than 18 years.&#xD;
  &#xD;
            -  Principal residence within the geographic reach of our MIH program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnant women&#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>Zachary Dewar</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Guthrie Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zachary Dewar, MD</last_name>
      <phone>570-887-4882</phone>
      <email>Zachary.Dewar@guthrie.org</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ultrasound</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05980533
  org study id: 2307-41
  nct id: NCT05980533
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to use a handheld ultrasound to assess patients with
        congestive heart failure (CHF) to see if the ultrasound can help predict readmission to the
        hospital. The study will include patients who are admitted to the hospital for CHF.
        Participants will have two ultrasounds at hospital discharge and at a follow up visit.
  The purpose of this research is to see if a portable ultrasound can help predict readmission
        to the hospital for patients who are admitted to the hospital for CHF. The study will enroll
        patients who take part in Mobile Integrated Healthcare as part of their routine care.
        Participants will have two ultrasounds. The first ultrasound will be at hospital discharge.
  
        Between seven to ten days after hospital discharge participants will be visited at their home
        in follow-up as the usual standard of care for Mobile Integrated Healthcare. At this visit
        participants will have a second ultrasound. Participants will be followed for one year for
        hospital readmission.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Hospital Readmission
  time frame: 30 days
  description: Hospital readmission within 30 days of discharge
  arm group label: Ultrasound
  arm group type: Experimental
  description: Ultrasound at hospital discharge and at follow up in 7-10 days
  intervention type: Diagnostic Test
  intervention name: Ultrasound
  description: Ultrasound at hospital discharge and at follow up at 7-10 days
  arm group label: Ultrasound
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zachary Dewar
  role: Principal Investigator
  affiliation: The Guthrie Clinic
  last name: Zachary Dewar, MD
  phone: 570-887-4882
  email: Zachary.Dewar@guthrie.org
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No