EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtectio... | NCT04445493

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

NCT04445493

Sponsor

MindRhythm, Inc.

Status

Completed

Last Update Posted

Feb 8, 2023Actual

Enrollment

486Actual

Phase

Not provided

Conditions

Stroke, Acute
COVID-19

Interventions

MindRhythm Harmony

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Jun 18, 2020

First Submission Date that Met QC Criteria

Jun 22, 2020

First Posted Date

Jun 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2023

Last Update Posted Date

Feb 8, 2023Actual

Name	Class
Wayne State University	OTHER
Western Michigan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

486Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device: MindRhythm Harmony		Passive recording of the head pulse	Device: MindRhythm Harmony

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MindRhythm Harmony	Device	Passive recording of the head pulse	Device: MindRhythm Harmony

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are being evaluated in the prehospital environment by Detroit Paramedics/EMTs in whom stroke is suspected and who may be at risk fo COVID-19 infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Paxton, MD	Wayne State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wayne State University		Detroit	Michigan	48201	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31591693	Result	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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases