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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04445493
Acronym
EPISODE-PH-COV
Enrollment
486
Registered
2020-06-24
Start date
2021-03-01
Completion date
2023-01-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Stroke, Acute

Brief summary

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.

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

DEVICEMindRhythm Harmony

Passive recording of the head pulse

Sponsors

Wayne State University
CollaboratorOTHER
Western Michigan University
CollaboratorOTHER
MindRhythm, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality head pulse recordingsThrough Study Completion, an average 6 monthsProportion of head pulse studies deemed of high quality for further analysis
Prevalence of COVID-19 infection in suspected stroke populationThrough Study Completion, an average of 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026