<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/NCT04445493</url>
  </required_header>
  <id_info>
    <org_study_id>EPISODE-PH-COVID</org_study_id>
    <nct_id>NCT04445493</nct_id>
  </id_info>
  <brief_title>EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )</brief_title>
  <acronym>EPISODE-PH-COV</acronym>
  <official_title>EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MindRhythm, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Western Michigan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MindRhythm, Inc.</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>
      Prehospital providers encounter patients with suspected stroke frequently. Stroke and&#xD;
      COVID-19 are related potentially putting these healthcare workers at risk of COVID-19&#xD;
      infection. In addition, prehospital providers need tools to help triage large vessel stroke&#xD;
      patients to comprehensive stroke centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observational prospective study will document COVID-19 status on patients seen in the&#xD;
      prehospital environment for suspected stroke. This will provide an estimate of how frequently&#xD;
      stroke occurs in stroke and also the exposure risk to providers in this setting.&#xD;
&#xD;
      Additionally, patients will have a headset placed to record their headpulse during the&#xD;
      encounter. These measurements will be used to further develop an analytic model used to&#xD;
      predict the presence of large vessel occlusion (LVO) stroke. This may help create a device&#xD;
      that can be used in the prehospital environment to aid in the trade decision of destination&#xD;
      hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Actual">January 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 1, 2023</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>Prevalence of COVID-19 infection in suspected stroke population</measure>
    <time_frame>Through Study Completion, an average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality head pulse recordings</measure>
    <time_frame>Through Study Completion, an average 6 months</time_frame>
    <description>Proportion of head pulse studies deemed of high quality for further analysis</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">486</enrollment>
  <condition>Stroke, Acute</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Device: MindRhythm Harmony</arm_group_label>
    <description>Passive recording of the head pulse</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MindRhythm Harmony</intervention_name>
    <description>Passive recording of the head pulse</description>
    <arm_group_label>Device: MindRhythm Harmony</arm_group_label>
    <other_name>Cranial Accelerometry</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are being evaluated in the prehospital environment by Detroit Paramedics/EMTs&#xD;
        in whom stroke is suspected and who may be at risk fo COVID-19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suspected stroke in the prehospital setting&#xD;
&#xD;
          -  patient at risk for COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  scalp laceration&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Prisoner, other vulnerable population&#xD;
&#xD;
          -  Prehospital provider feels that the recording may interfere with care&#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>James Paxton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.</citation>
    <PMID>31591693</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 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>COVID-19</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</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/NCT04445493
org study id: EPISODE-PH-COVID
nct id: NCT04445493
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prehospital providers encounter patients with suspected stroke frequently. Stroke and
      COVID-19 are related potentially putting these healthcare workers at risk of COVID-19
      infection. In addition, prehospital providers need tools to help triage large vessel stroke
      patients to comprehensive stroke centers.
This observational prospective study will document COVID-19 status on patients seen in the
      prehospital environment for suspected stroke. This will provide an estimate of how frequently
      stroke occurs in stroke and also the exposure risk to providers in this setting.

      Additionally, patients will have a headset placed to record their headpulse during the
      encounter. These measurements will be used to further develop an analytic model used to
      predict the presence of large vessel occlusion (LVO) stroke. This may help create a device
      that can be used in the prehospital environment to aid in the trade decision of destination
      hospital.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of COVID-19 infection in suspected stroke population
time frame: Through Study Completion, an average of 6 months
measure: Quality head pulse recordings
time frame: Through Study Completion, an average 6 months
description: Proportion of head pulse studies deemed of high quality for further analysis
arm group label: Device: MindRhythm Harmony
description: Passive recording of the head pulse
intervention type: Device
intervention name: MindRhythm Harmony
description: Passive recording of the head pulse
arm group label: Device: MindRhythm Harmony
other name: Cranial Accelerometry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Paxton, MD
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
citation: Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.
PMID: 31591693
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No