Detection of hEad Pulse for Ischemic StrOke Verification Study
EPISODE_VS
EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
1 other identifier
observational
500
1 country
1
Brief Summary
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedJuly 28, 2023
June 1, 2023
4 months
October 27, 2022
July 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®.
The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the "ground truth" diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions).
Through study completion, an average of 6 months
Study Arms (1)
MINDRHYTHM HARMONY
Passive Recording of the head pulse
Interventions
Eligibility Criteria
Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.
You may qualify if:
- suspected stroke in the prehospital setting
You may not qualify if:
- scalp laceration
- Patient refusal
- Prisoner, other vulnerable population
- Prehospital provider feels that the recording may interfere with care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MindRhythm, Inc.lead
- Wayne State Universitycollaborator
Study Sites (1)
Wayne Health
Detroit, Michigan, 48201, United States
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: 31591693BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Paxton, MD
Wayne State University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2022
First Posted
November 2, 2022
Study Start
June 15, 2023
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
July 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share