<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/NCT02187770</url>
  </required_header>
  <id_info>
    <org_study_id>CP-000040</org_study_id>
    <nct_id>NCT02187770</nct_id>
  </id_info>
  <brief_title>Precision of IMED-4 Lung Fluid Measurements</brief_title>
  <official_title>Precision of IMED-4 Lung Fluid Measurements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intersection Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intersection Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if IMED-4 recordings have sufficient precision to&#xD;
      detect a clinically significant change in lung fluid status in acute heart failure syndrome&#xD;
      with pulmonary congestion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate if the IMED-4 system has the precision to detect a clinically&#xD;
      significant change in lung fluid status for patients with confirmed acute heart failure&#xD;
      syndrome with pulmonary congestion. Changes in lung fluid in acute heart failure syndrome are&#xD;
      difficult to diagnose and evaluate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Lung Fluid Status</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>IMED 4 is a new device to measure lung fluid status by assessing how wet or dry the lungs are</description>
  </primary_outcome>
  <enrollment type="Actual">46</enrollment>
  <condition>Dyspnea</condition>
  <condition>Acute Heart Failure Syndrome</condition>
  <condition>Pulmonary Congestion</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IMED-4</intervention_name>
    <description>Non invasive recording electrode used to assess lung fluid</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are admitted for inpatient management with acute heart failure syndrome with&#xD;
        pulmonary congestion are possible candidates for the study and shall be screened for&#xD;
        suitability based on the inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Diagnosed with acute heart failure syndrome with pulmonary congestion defined by a&#xD;
             Brain natriuretic peptide (BNP) &gt;350 pg/mL or N-terminal pro-brain natriuretic peptide&#xD;
             (NT-pro BNP) &gt;1500 pg/mL and any one of the following:&#xD;
&#xD;
               1. PCWP &gt;25mmHg&#xD;
&#xD;
               2. Dyspnea at rest in a recumbent sitting position (30 to 45 degrees), which has&#xD;
                  worsened within the past week&#xD;
&#xD;
               3. Radiological evidence of CHF on a chest X-ray&#xD;
&#xD;
               4. Physical exam as evidence for pulmonary congestion:&#xD;
&#xD;
             i. Presence of an S3 heart sound ii. Lung rales/crackles/crepitations&#xD;
&#xD;
          2. Age greater than or equal to (≥) 18&#xD;
&#xD;
          3. Ability to reliably carry out self-assessment of symptoms&#xD;
&#xD;
          4. Willingness, ability and commitment to participate in index and follow-up IMED-4&#xD;
             recordings&#xD;
&#xD;
        EXCLUSION Criteria&#xD;
&#xD;
          1. Known active myocarditis, obstructive hypertrophic cardiomyopathy, constrictive&#xD;
             pericarditis, uncorrected clinically significant primary valvular disease&#xD;
&#xD;
          2. Clinical diagnosis of acute coronary syndrome meeting any 2 of the following 3&#xD;
             criteria:&#xD;
&#xD;
               1. Prolonged chest pain at rest, or an accelerated pattern of angina&#xD;
&#xD;
               2. Electrocardiogram changes indicative of ischemia or myocardial injury&#xD;
&#xD;
               3. Serum troponin &gt;3 times upper limit of lab normal&#xD;
&#xD;
          3. Clinically-suspected acute mechanical cause of ADHF (e.g., papillary muscular&#xD;
             rupture); the diagnosis need not be confirmed by imaging or cardiac catheterization&#xD;
&#xD;
          4. Estimated Glomerular Filtration Rate: eGFR &lt;30mL/min/1.73m&#xD;
&#xD;
          5. Known vasculitis, active infective endocarditis, or suspected infections including&#xD;
             pneumonia, acute hepatitis, systemic inflammatory response syndrome, or sepsis&#xD;
&#xD;
          6. Body temperature ≥38°C just prior to enrollment&#xD;
&#xD;
          7. Acute or chronic respiratory disorder (e.g. severe chronic obstructive pulmonary&#xD;
             disease (COPD)) or primary pulmonary hypertension sufficient to cause dyspnea at rest,&#xD;
             which may interfere with the ability to interpret dyspnea assessments or hemodynamic&#xD;
             measurements&#xD;
&#xD;
          8. Total Albumin &lt;2.5 g/dL&#xD;
&#xD;
          9. Patients requiring mechanical circulatory support&#xD;
&#xD;
         10. Pregnancy or lactation&#xD;
&#xD;
         11. Patients who have tattoos and/or non-intact skin directly under the electrode sensor&#xD;
             position&#xD;
&#xD;
         12. Patients who have had past allergic reactions to medical grade adhesives&#xD;
&#xD;
         13. Patients who have had a lung lobectomy&#xD;
&#xD;
         14. Patients who decline to have their backs photographed with the IMED-4 device in&#xD;
             position&#xD;
&#xD;
         15. Severe co-morbidity or poor general physical/mental health that, in the opinion of the&#xD;
             Investigator, will not allow the subject to be a good study candidate (i.e. other&#xD;
             disease processes, mental capacity, substance abuse, incarceration, shortened life&#xD;
             expectance, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mass General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</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>Dyspnea</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/NCT02187770
org study id: CP-000040
nct id: NCT02187770
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if IMED-4 recordings have sufficient precision to
      detect a clinically significant change in lung fluid status in acute heart failure syndrome
      with pulmonary congestion.
The study will evaluate if the IMED-4 system has the precision to detect a clinically
      significant change in lung fluid status for patients with confirmed acute heart failure
      syndrome with pulmonary congestion. Changes in lung fluid in acute heart failure syndrome are
      difficult to diagnose and evaluate.
observational model: Case-Only
time perspective: Prospective
measure: Lung Fluid Status
time frame: Up to 1 year
description: IMED 4 is a new device to measure lung fluid status by assessing how wet or dry the lungs are
intervention type: Device
intervention name: IMED-4
description: Non invasive recording electrode used to assess lung fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dyspnea