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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445493
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Wayne State University
Information provided by (Responsible Party):
MindRhythm, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Stroke, Acute COVID-19 Device: MindRhythm Harmony

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Device: MindRhythm Harmony
Passive recording of the head pulse
 Device: MindRhythm Harmony
Passive recording of the head pulse
Other Name: Cranial Accelerometry


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445493


Contacts
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Contact: Lisa Distenfield 954-552-4206 lisa.distenfield@mindrhythm.com
Contact: Paul Lovoi, Ph.D 408-230-6396 paul.lovoi@mindrhythm.com

Locations
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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: James Paxton, MD    313-966-6119      
Contact: Kathy Cross    313-966-6110      
Sponsors and Collaborators
MindRhythm, Inc.
Wayne State University
Investigators
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Principal Investigator: James Paxton, MD Wayne State University
More Information
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Publications of Results:

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Responsible Party: MindRhythm, Inc.
ClinicalTrials.gov Identifier: NCT04445493    
Other Study ID Numbers: EPISODE-PH-COVID
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases