<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/NCT01671371</url>
  </required_header>
  <id_info>
    <org_study_id>1110009227</org_study_id>
    <nct_id>NCT01671371</nct_id>
  </id_info>
  <brief_title>Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope</brief_title>
  <official_title>A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope</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 study is to determine whether point-of-care (bedside) ultrasound assists&#xD;
      physicians in the evaluation and management of patients with syncope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Syncope is one of the more common presentations to the Emergency Department, representing&#xD;
      between 1.2-1.5% of all evaluated patients and up to 6% of admissions. Due to an often broad&#xD;
      and overlapping differential diagnosis, syncope represents a disease entity that often&#xD;
      requires extensive workup. This typically involves laboratory tests, EKGs, x-rays, computed&#xD;
      tomography, or other studies that are costly, time-consuming, and, in the case of diagnostic&#xD;
      imaging, frequently involves ionizing radiation. Yet, despite extensive testing, an exact&#xD;
      diagnosis is not made in up to 50% of cases.&#xD;
&#xD;
      Cardiac causes of syncope include myocardial infarction, pericardial effusion, volume&#xD;
      depletion, arrhythmia, among other entities, many of which are life threatening.&#xD;
      Echocardiography (cardiac ultrasound) has been used for inpatient syncope evaluations for&#xD;
      several decades. In the Emergency Department, echocardiography is currently being used at the&#xD;
      point-of-care (POC) in a limited and focused approach to a variety of conditions. However,&#xD;
      POC ultrasound has never been systematically evaluated as a diagnostic or prognostic tool&#xD;
      specifically for syncope in the Emergency Department. We aim to determine if an&#xD;
      ultrasound-based protocol is effective as an adjunct in the evaluation of syncope. Our&#xD;
      research study will examine the utility of POC ultrasound in the diagnosis, imaging and&#xD;
      laboratory utilization, and prognosis of syncope in the Emergency Department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    unable to meet enrollment projections&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Final Emergency Department Disposition</measure>
    <time_frame>Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to therapeutic intervention</measure>
    <time_frame>At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to clinical procedure</measure>
    <time_frame>At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Type of other imaging studies</measure>
    <time_frame>End of Emergency Department Encounter (estimated time frame 1- 6 hours)</time_frame>
    <description>Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Information Content provided by Point-of-Care Ultrasound</measure>
    <time_frame>After performance of point-of-care ultrasound (estimated time frame 1- 6 hours)</time_frame>
    <description>calculating from pre and post test probability estimates and the number of diagnoses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of laboratory studies</measure>
    <time_frame>estimated time frame 0-6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of and time to consultant services</measure>
    <time_frame>estimated time frame (0-6 hours)</time_frame>
    <description>Number of consults obtained and the time frame in which the consults were performed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Short Term Adverse Outcome</measure>
    <time_frame>7 days from Emergency Department Visit</time_frame>
    <description>Adverse outcome defined as death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Syncope</condition>
  <arm_group>
    <arm_group_label>Immediate Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Ultrasound</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Point-of-Care Ultrasound</intervention_name>
    <description>Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility</description>
    <arm_group_label>Delayed Ultrasound</arm_group_label>
    <arm_group_label>Immediate Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older presenting to the ED with acute syncope (defined as transient loss&#xD;
             of consciousness) or near syncope (sensation of impending but not actual loss of&#xD;
             consciousness) as a reason for ED visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persistent altered mental status&#xD;
&#xD;
          -  alcohol or illicit drug-related loss of consciousness&#xD;
&#xD;
          -  definite seizure, and transient loss of consciousness caused by head trauma.&#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, M.D.</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>
  <reference>
    <citation>Keller C, Tristano JM, De Lorenzo R, et al.</citation>
  </reference>
  <reference>
    <citation>Grossman SA, Fischer C, Lipsitz LA, Mottley L, Sands K, Thompson S, Zimetbaum P, Shapiro NI. Predicting adverse outcomes in syncope. J Emerg Med. 2007 Oct;33(3):233-9. doi: 10.1016/j.jemermed.2007.04.001. Epub 2007 Jul 5.</citation>
    <PMID>17976548</PMID>
  </reference>
  <reference>
    <citation>Dhatreecharan S, Azar P, Werner MS, et al.</citation>
  </reference>
  <reference>
    <citation>Gabayan GZ, Derose SF, Asch SM, Chiu VY, Glenn SC, Mangione CM, Sun BC. Predictors of short-term (seven-day) cardiac outcomes after emergency department visit for syncope. Am J Cardiol. 2010 Jan 1;105(1):82-6. doi: 10.1016/j.amjcard.2009.08.654.</citation>
    <PMID>20102895</PMID>
  </reference>
  <reference>
    <citation>Martin NM, Picard MH. Use and appropriateness of transthoracic echocardiography in an academic medical center: a pilot observational study. J Am Soc Echocardiogr. 2009 Jan;22(1):48-52. doi: 10.1016/j.echo.2008.10.003. Epub 2008 Nov 20.</citation>
    <PMID>19022620</PMID>
  </reference>
  <reference>
    <citation>Christopher L Moore and Joshua A Copel.</citation>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 17, 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>syncope</keyword>
  <keyword>point of care</keyword>
  <keyword>ultrasound</keyword>
  <keyword>echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Emergencies</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/NCT01671371
org study id: 1110009227
nct id: NCT01671371
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists
      physicians in the evaluation and management of patients with syncope.
Syncope is one of the more common presentations to the Emergency Department, representing
      between 1.2-1.5% of all evaluated patients and up to 6% of admissions. Due to an often broad
      and overlapping differential diagnosis, syncope represents a disease entity that often
      requires extensive workup. This typically involves laboratory tests, EKGs, x-rays, computed
      tomography, or other studies that are costly, time-consuming, and, in the case of diagnostic
      imaging, frequently involves ionizing radiation. Yet, despite extensive testing, an exact
      diagnosis is not made in up to 50% of cases.

      Cardiac causes of syncope include myocardial infarction, pericardial effusion, volume
      depletion, arrhythmia, among other entities, many of which are life threatening.
      Echocardiography (cardiac ultrasound) has been used for inpatient syncope evaluations for
      several decades. In the Emergency Department, echocardiography is currently being used at the
      point-of-care (POC) in a limited and focused approach to a variety of conditions. However,
      POC ultrasound has never been systematically evaluated as a diagnostic or prognostic tool
      specifically for syncope in the Emergency Department. We aim to determine if an
      ultrasound-based protocol is effective as an adjunct in the evaluation of syncope. Our
      research study will examine the utility of POC ultrasound in the diagnosis, imaging and
      laboratory utilization, and prognosis of syncope in the Emergency Department.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Time to Final Emergency Department Disposition
time frame: Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)
measure: Time to therapeutic intervention
time frame: At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours)
measure: Time to clinical procedure
time frame: At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours)
measure: Number and Type of other imaging studies
time frame: End of Emergency Department Encounter (estimated time frame 1- 6 hours)
description: Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.
measure: Information Content provided by Point-of-Care Ultrasound
time frame: After performance of point-of-care ultrasound (estimated time frame 1- 6 hours)
description: calculating from pre and post test probability estimates and the number of diagnoses
measure: Number and type of laboratory studies
time frame: estimated time frame 0-6 hours
measure: Number of and time to consultant services
time frame: estimated time frame (0-6 hours)
description: Number of consults obtained and the time frame in which the consults were performed
measure: Short Term Adverse Outcome
time frame: 7 days from Emergency Department Visit
description: Adverse outcome defined as death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.
arm group label: Immediate Ultrasound
arm group type: Other
description: A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)
arm group label: Delayed Ultrasound
arm group type: Other
description: A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization
intervention type: Other
intervention name: Point-of-Care Ultrasound
description: Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility
arm group label: Delayed Ultrasound
arm group label: Immediate Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard A Taylor, M.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
citation: Keller C, Tristano JM, De Lorenzo R, et al.
citation: Grossman SA, Fischer C, Lipsitz LA, Mottley L, Sands K, Thompson S, Zimetbaum P, Shapiro NI. Predicting adverse outcomes in syncope. J Emerg Med. 2007 Oct;33(3):233-9. doi: 10.1016/j.jemermed.2007.04.001. Epub 2007 Jul 5.
PMID: 17976548
citation: Dhatreecharan S, Azar P, Werner MS, et al.
citation: Gabayan GZ, Derose SF, Asch SM, Chiu VY, Glenn SC, Mangione CM, Sun BC. Predictors of short-term (seven-day) cardiac outcomes after emergency department visit for syncope. Am J Cardiol. 2010 Jan 1;105(1):82-6. doi: 10.1016/j.amjcard.2009.08.654.
PMID: 20102895
citation: Martin NM, Picard MH. Use and appropriateness of transthoracic echocardiography in an academic medical center: a pilot observational study. J Am Soc Echocardiogr. 2009 Jan;22(1):48-52. doi: 10.1016/j.echo.2008.10.003. Epub 2008 Nov 20.
PMID: 19022620
citation: Christopher L Moore and Joshua A Copel.
responsible party type: Sponsor
mesh term: Syncope
mesh term: Emergencies