<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/NCT01671618</url>
  </required_header>
  <id_info>
    <org_study_id>1202009791</org_study_id>
    <nct_id>NCT01671618</nct_id>
  </id_info>
  <brief_title>Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta</brief_title>
  <official_title>A Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Assessing for Thoracic Aortic Dimensions, Dilation, and Aneurysm in Correlation With CT Angiogram in Suspected Cases of Pathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound&#xD;
      (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending&#xD;
      aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the&#xD;
      measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nonspecific chest pain is frequently encountered in the emergency department. Accounting for&#xD;
      over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest&#xD;
      pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic&#xD;
      aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic&#xD;
      echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own&#xD;
      advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound&#xD;
      (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of&#xD;
      undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have&#xD;
      good agreement. This studies aims to confirm these findings through prospective evaluation&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
      Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to&#xD;
      thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic&#xD;
      dimensions.&#xD;
&#xD;
      Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to&#xD;
      CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and&#xD;
      statistical significance.&#xD;
&#xD;
      Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.&#xD;
&#xD;
      Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for&#xD;
      the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography&#xD;
      as the reference standard&#xD;
&#xD;
      Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference&#xD;
      standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS</measure>
    <time_frame>during emergency department visit (estimated average 3-6 hours)</time_frame>
    <description>Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Emergency Department Disposition</measure>
    <time_frame>estimated time frame 3-6 hours</time_frame>
    <description>Time until an admission or discharge order is placed within the electronic medical record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and percent probabilities of differential diagnosis</measure>
    <time_frame>(estimated time frame 0 -3 hours)</time_frame>
    <description>Number and percent probabilities of differential diagnosis will be obtained before and after ultrasound to calculate the informational content provided by the ultrasound and perform additional uncertainty analyses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to diagnostic imaging</measure>
    <time_frame>estimated time frame 0-6 hours</time_frame>
    <description>Time when diagnostic imaging is performed</description>
  </secondary_outcome>
  <enrollment type="Actual">97</enrollment>
  <condition>Aortic Aneurysm, Thoracic</condition>
  <condition>Aortic Dissection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients 18 years of age or older presenting to an urban, academic, and level I emergency&#xD;
        department with estimated volume of approximately 90,000 patients per year.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients aged 18 years and older presenting to the ED for whom a thoracic CTA has&#xD;
             been ordered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of verbal consent for ultrasound.&#xD;
&#xD;
          -  Inability to obtain informed written consent for data collection from either the&#xD;
             patient or the patients decision-making surrogate&#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>Richard A Taylor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>June 29, 2016</last_update_submitted>
  <last_update_submitted_qc>June 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic dissection</keyword>
  <keyword>Aortic dilation</keyword>
  <keyword>Aortic Aneurysm</keyword>
  <keyword>ultrasound</keyword>
  <keyword>point-of-care</keyword>
  <keyword>echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Thoracic</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/NCT01671618
org study id: 1202009791
nct id: NCT01671618
lead sponsor: 
has dmc: No
The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound
      (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending
      aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the
      measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal
      disease.
Nonspecific chest pain is frequently encountered in the emergency department. Accounting for
      over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest
      pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic
      aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic
      echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own
      advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound
      (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of
      undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have
      good agreement. This studies aims to confirm these findings through prospective evaluation

      Specific Aims

      Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to
      thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic
      dimensions.

      Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to
      CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and
      statistical significance.

      Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.

      Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for
      the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography
      as the reference standard

      Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference
      standard.
observational model: Cohort
time perspective: Prospective
measure: Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS
time frame: during emergency department visit (estimated average 3-6 hours)
description: Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.
measure: Time to Emergency Department Disposition
time frame: estimated time frame 3-6 hours
description: Time until an admission or discharge order is placed within the electronic medical record
measure: Number and percent probabilities of differential diagnosis
time frame: (estimated time frame 0 -3 hours)
description: Number and percent probabilities of differential diagnosis will be obtained before and after ultrasound to calculate the informational content provided by the ultrasound and perform additional uncertainty analyses
measure: Time to diagnostic imaging
time frame: estimated time frame 0-6 hours
description: Time when diagnostic imaging is performed
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard A Taylor, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aortic Dissection
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Thoracic