EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )

Overview

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.

Full Title of Study: “EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2023

Detailed Description

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.

Interventions

  • Device: MindRhythm Harmony
    • Passive recording of the head pulse

Arms, Groups and Cohorts

  • Device: MindRhythm Harmony
    • Passive recording of the head pulse

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of COVID-19 infection in suspected stroke population
    • Time Frame: Through Study Completion, an average of 6 months
  • Quality head pulse recordings
    • Time Frame: Through Study Completion, an average 6 months
    • Proportion of head pulse studies deemed of high quality for further analysis

Participating in This Clinical Trial

Inclusion Criteria

  • suspected stroke in the prehospital setting – patient at risk for COVID-19 Exclusion Criteria:

  • scalp laceration – Patient refusal – Prisoner, other vulnerable population – Prehospital provider feels that the recording may interfere with care

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MindRhythm, Inc.
  • Collaborator
    • Wayne State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Paxton, MD, Principal Investigator, Wayne State University

Citations Reporting on Results

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.

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