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Completed

NCT Number: NCT04445493

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

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.

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Key information

Conditions

Stroke, Acute Brain Diseases COVID-19 Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wayne State University

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MindRhythm Harmony

Device

Passive recording of the head pulse

Other names: Cranial Accelerometry

Primary outcomes

  1. Prevalence of COVID-19 infection in suspected stroke population

    Time frame: Through Study Completion, an average of 6 months

  2. 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

Sponsors and collaborators

Lead sponsor

MindRhythm, Inc.

Industry

Collaborators

  • Wayne State University
  • Western Michigan University

Registry information

Official study title

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

Acronym: EPISODE-PH-COV

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 24, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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