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

NCT04445493 | Completed

• 1 other identifier: EPISODE-PH-COVID
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device: MindRhythm Harmony

Passive recording of the head pulse

Device: MindRhythm Harmony

Interventions

MindRhythm Harmony DEVICE

Passive recording of the head pulse

Also known as: Cranial Accelerometry

Device: MindRhythm Harmony

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• suspected stroke in the prehospital setting
• patient at risk for COVID-19

You may not qualify if:

• scalp laceration
• Patient refusal
• Prisoner, other vulnerable population
• Prehospital provider feels that the recording may interfere with care

Sponsors & Collaborators

• MindRhythm, Inc.: lead
• Wayne State University: collaborator
• Western Michigan University: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• 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.

  PMID: 31591693 RESULT

MeSH Terms

Conditions

Stroke; COVID-19

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• James Paxton, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 24, 2020
• Study Start: March 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)