<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/NCT02996032</url>
  </required_header>
  <id_info>
    <org_study_id>H-35112</org_study_id>
    <nct_id>NCT02996032</nct_id>
  </id_info>
  <brief_title>CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study</brief_title>
  <acronym>CRUSH</acronym>
  <official_title>CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart Failure Society of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emergency Medicine Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can&#xD;
      predict patients at higher risk of readmission within 30 days of hospital discharge for&#xD;
      decompensated heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure (HF) resulting in congestion is the leading cause for admission in persons ≥65&#xD;
      years of age and 20-25% of such patients are readmitted within 30 days of discharge. Efforts&#xD;
      to treat HF are difficult without a simple method to detect early signs of congestion to&#xD;
      direct therapy. Ultrasound can detect evidence of congestion by increased cardiac filling&#xD;
      pressures two weeks prior to other markers of congestion such as weight gain or patient&#xD;
      symptoms. Corrected flow time (FTc) measured by ultrasound, is an easy to perform vascular&#xD;
      measure and correlates with cardiac filling pressures. Despite the relationship between FTc&#xD;
      and filling pressures, this measure has never been studied in HF. The primary aim is to&#xD;
      determine if FTc can predict patients at risk of readmission within 30 days. As a secondary&#xD;
      aim, the investigators plan to validate a small study of patients reporting the ability of&#xD;
      pulmonary ultrasound to predict readmissions. This study demonstrated pulmonary ultrasound&#xD;
      was 100% sensitive and 68% specific for predicting readmission at 3 months, however this&#xD;
      investigation was small and validation is needed. It is expected ultrasound will be able to&#xD;
      accurately and safely predict patients who will be readmitted within 30 days of discharge.&#xD;
      This proposal is aimed at identifying a noninvasive measure to better assess congestion from&#xD;
      HF and predict readmissions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>Change in Corrected Flow Time</measure>
    <time_frame>Measured daily during hospitalization and then correlated to 30 day readmissions.Mean hospitalization for the study population is 9 days, but will be measured during the duration of their hospitalization.</time_frame>
    <description>Daily corrected flow time measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of their hospitalization. Changes in corrected flow time values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Corrected Flow Time is a single measure performed serial with the same units of measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Ultrasound (B-Lines)</measure>
    <time_frame>Measured daily during hospitalization and correlated to 30 day readmissions. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of hospitalization.</time_frame>
    <description>Daily pulmonary ultrasound measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured for the duration of their hospitalization. Changes in lung ultrasound values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Lung Ultrasound is a single measure performed serial with the same units of measure.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">187</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Failure</arm_group_label>
    <description>Patients admitted to the hospital with acute decompensated heart failure expected to be hospitalized for at least 72 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vascular and Pulmonary Ultrasound</intervention_name>
    <arm_group_label>Heart Failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients hospitalized with a diagnosis of acute decompensated heart failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English Speaking&#xD;
&#xD;
          -  Being admitted for heart failure with expected hospital stay of 72 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide 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_official>
    <last_name>Joseph Pare, MD MHS RDMS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Medical Center</investigator_affiliation>
    <investigator_full_name>Joseph Pare</investigator_full_name>
    <investigator_title>Assistant Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <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>


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/NCT02996032
org study id: H-35112
nct id: NCT02996032
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can
      predict patients at higher risk of readmission within 30 days of hospital discharge for
      decompensated heart failure.
Heart failure (HF) resulting in congestion is the leading cause for admission in persons ≥65
      years of age and 20-25% of such patients are readmitted within 30 days of discharge. Efforts
      to treat HF are difficult without a simple method to detect early signs of congestion to
      direct therapy. Ultrasound can detect evidence of congestion by increased cardiac filling
      pressures two weeks prior to other markers of congestion such as weight gain or patient
      symptoms. Corrected flow time (FTc) measured by ultrasound, is an easy to perform vascular
      measure and correlates with cardiac filling pressures. Despite the relationship between FTc
      and filling pressures, this measure has never been studied in HF. The primary aim is to
      determine if FTc can predict patients at risk of readmission within 30 days. As a secondary
      aim, the investigators plan to validate a small study of patients reporting the ability of
      pulmonary ultrasound to predict readmissions. This study demonstrated pulmonary ultrasound
      was 100% sensitive and 68% specific for predicting readmission at 3 months, however this
      investigation was small and validation is needed. It is expected ultrasound will be able to
      accurately and safely predict patients who will be readmitted within 30 days of discharge.
      This proposal is aimed at identifying a noninvasive measure to better assess congestion from
      HF and predict readmissions.
observational model: Cohort
time perspective: Prospective
measure: Change in Corrected Flow Time
time frame: Measured daily during hospitalization and then correlated to 30 day readmissions.Mean hospitalization for the study population is 9 days, but will be measured during the duration of their hospitalization.
description: Daily corrected flow time measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of their hospitalization. Changes in corrected flow time values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Corrected Flow Time is a single measure performed serial with the same units of measure.
measure: Change in Pulmonary Ultrasound (B-Lines)
time frame: Measured daily during hospitalization and correlated to 30 day readmissions. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of hospitalization.
description: Daily pulmonary ultrasound measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured for the duration of their hospitalization. Changes in lung ultrasound values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Lung Ultrasound is a single measure performed serial with the same units of measure.
arm group label: Heart Failure
description: Patients admitted to the hospital with acute decompensated heart failure expected to be hospitalized for at least 72 hours
intervention type: Other
intervention name: Vascular and Pulmonary Ultrasound
arm group label: Heart Failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Pare, MD MHS RDMS
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Medical Center
investigator full name: Joseph Pare
investigator title: Assistant Professor of Emergency Medicine
mesh term: Heart Failure
sharing ipd: No