HeadPulse Large Vessel Occlusion Validation Study

NCT05719272 | Unknown

• 1 other identifier: EPISODE_LVO_MR1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• HeadPulse Waveform Data

  Waveform data associated with the changes in brain function as a result of the cranial effect of the. cardiac cycle

  90 seconds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients who have experienced and have a confirmed ischemic stroke of the most critical type: a large vessel occlusion who are admitted to the hospital.

You may qualify if:

• adult patient Known LVO (transferred or arrived at our ED) ICA-T, M1, M2 or Basilar Artery Recording can be made just prior to thrombectomy, or within 2 hours of CTA and no thrombectomy performed

You may not qualify if:

• Prisoner Open scalp wound

Sponsors & Collaborators

• MindRhythm, Inc.: lead
• University at Buffalo: collaborator
• The Cooper Health System: collaborator

Study Sites (2)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

University at Buffalo

Buffalo, New York, 14206, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul Lovoi, PhD

  CTO of Sponsor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: February 8, 2023
• Study Start: November 16, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 30, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (2)