- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05602740
Detection of hEad Pulse for Ischemic StrOke Verification Study (EPISODE_VS)
July 26, 2023 updated by: MindRhythm, Inc.
EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
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.
Study Overview
Detailed Description
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter.
These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke.
The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Distenfield
- Phone Number: 954-552-4206
- Email: lisa.distenfield@mindrhythm.com
Study Contact Backup
- Name: Paul Lovoi, Ph.D.
- Phone Number: 408-230-6396
- Email: paul.lovoi@mindrhythm.com
Study Locations
-
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients who are being evaluated in the prehospital environment by Paramedics/EMTs in whom stroke is suspected.
Description
Inclusion Criteria:
• suspected stroke in the prehospital setting
Exclusion Criteria:
- scalp laceration
- Patient refusal
- Prisoner, other vulnerable population
- Prehospital provider feels that the recording may interfere with care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
MINDRHYTHM HARMONY
Passive Recording of the head pulse
|
Passive recording of the head pulse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®.
Time Frame: Through study completion, an average of 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James Paxton, MD, Wayne State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2023
Primary Completion (Estimated)
October 1, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
October 27, 2022
First Submitted That Met QC Criteria
October 27, 2022
First Posted (Actual)
November 2, 2022
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 26, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPISODE_VS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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