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

NCT ID: NCT04445493

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Stroke, Acute COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Device: MindRhythm Harmony

Passive recording of the head pulse

MindRhythm Harmony

Intervention Type DEVICE

Passive recording of the head pulse

Interventions

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MindRhythm Harmony

Passive recording of the head pulse

Intervention Type DEVICE

Other Intervention Names

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Cranial Accelerometry

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role collaborator

Western Michigan University

OTHER

Sponsor Role collaborator

MindRhythm, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Paxton, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 31591693 (View on PubMed)

Other Identifiers

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EPISODE-PH-COVID

Identifier Type: -

Identifier Source: org_study_id

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