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HeadPulse Large Vessel Occlusion Validation Study

NCT05719272 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-07-27

No results posted yet for this study

Summary

Acute ischemic stroke (AIS) is a treatable disease if patients can be transported and treated at stroke centers. MindRhythm, Inc (sponsor) has developed an investigational medical device that is designed for prehospital field use to differentiate the two major forms of acute ischemic stroke, namely Large Vessel Occlusion (LVO) stroke and non-large vessel occlusion stroke. The intended use is for paramedics to decide which destination hospital is best for the patient based on the device result. Large vessel occlusion stroke patients should be brought directly to comprehensive stroke centers which can perform thrombectomy, and non-large vessel occlusion stroke should be brought to primary stroke centers. Use of the device will save time getting the patient to thrombectomy and all others to intravenous thrombolytics or blood thinners that clear clots improves outcomes for all patients.

The Harmony 5000 device manufactured by MindRhythm has been tested in the pre-hospital environment, but because large vessel occlusion stroke is less common than non-large vessel occlusion stroke, the sponsor wants to obtain additional recordings from patients with large vessel occlusion to better refine their algorithms. Investigators will perform acute recordings on patients who arrive at the medical center who have computed tomography angiography studies showing the presence of large vessel occlusion stroke stroke, and on patients transferred to the angiography suite for thrombectomy. Recordings are performed in parallel to standard workflow of large vessel occlusion stroke patients so the research will not delay treatments.

Conditions

  • Stroke, Ischemic

Sponsors & Collaborators

  • University at Buffalo

    collaborator OTHER

  • The Cooper Health System

    collaborator OTHER

  • MindRhythm, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Lovoi, PhD · CTO of Sponsor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-16
Primary Completion
2025-01-01
Completion
2025-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05719272 on ClinicalTrials.gov