<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/NCT03824496</url>
  </required_header>
  <id_info>
    <org_study_id>17-21846</org_study_id>
    <nct_id>NCT03824496</nct_id>
  </id_info>
  <brief_title>Head Pulse for Ischemic Stroke Detection</brief_title>
  <acronym>EPISODE</acronym>
  <official_title>Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in&#xD;
      providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain&#xD;
      imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect&#xD;
      LVO is needed. Using highly sensitive accelerometers, one can measure the &quot;HeadPulse&quot;- tiny&#xD;
      forces exerted on the skull from the cardiac contraction. This study tests the hypothesis&#xD;
      that LVO alters the HeadPulse characteristically. Analysis of these data along with the&#xD;
      subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to&#xD;
      create a model that can predict LVO status in suspect stroke subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers.&#xD;
      Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of&#xD;
      thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to&#xD;
      comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke&#xD;
      centers.&#xD;
&#xD;
      EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or&#xD;
      absence of LVO based on recordings from a consecutive series of patients undergoing CTA for&#xD;
      suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared&#xD;
      to investigate whether a systematic change in cranial forces exists during LVO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 18, 2019</completion_date>
  <primary_completion_date type="Actual">August 18, 2019</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>Cranial accelerometry model</measure>
    <time_frame>Through study completion, likely 2 years</time_frame>
    <description>Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Suspected acute stroke</arm_group_label>
    <description>Any patient with suspected acute stroke triggering a &quot;stroke code&quot; and had a brain imaging angiogram</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cranial Accelerometry Measurement</intervention_name>
    <description>Measuring the HeadPulse using cranial accelerometry</description>
    <arm_group_label>Suspected acute stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been evaluated by a medical professional who feels the subject may be&#xD;
        experiencing an acute stroke and has triggered the acute stroke algorithm within the&#xD;
        medical center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected acute stroke&#xD;
&#xD;
          -  CTA or MRA performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient in whom obtaining a non-invasive recording is judged by the treating team&#xD;
             to interfere with clinical assessment or treatment of the patient.&#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>UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</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>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT03824496
org study id: 17-21846
nct id: NCT03824496
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in
      providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain
      imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect
      LVO is needed. Using highly sensitive accelerometers, one can measure the "HeadPulse"- tiny
      forces exerted on the skull from the cardiac contraction. This study tests the hypothesis
      that LVO alters the HeadPulse characteristically. Analysis of these data along with the
      subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to
      create a model that can predict LVO status in suspect stroke subjects.
Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers.
      Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of
      thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to
      comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke
      centers.

      EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or
      absence of LVO based on recordings from a consecutive series of patients undergoing CTA for
      suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared
      to investigate whether a systematic change in cranial forces exists during LVO.
observational model: Cohort
time perspective: Prospective
measure: Cranial accelerometry model
time frame: Through study completion, likely 2 years
description: Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects
arm group label: Suspected acute stroke
description: Any patient with suspected acute stroke triggering a "stroke code" and had a brain imaging angiogram
intervention type: Diagnostic Test
intervention name: Cranial Accelerometry Measurement
description: Measuring the HeadPulse using cranial accelerometry
arm group label: Suspected acute stroke
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No