SYNCHRONISE: LVO Triage Timing and Outcome Study

Stroke, Ischemic Clinical Trial

Official title:

Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions- SYNCHRONISE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608617
• Other study ID #: VIZ-LVO-03
• Status: Recruiting
• Start date: March 9, 2021
• Est. completion date: January 2026

Study information

• Verified date: April 2022
• Source: Viz.ai, Inc.
• Contact: Viz.ai Clinical Affairs
• Phone: 6503044355
• Email: evens[@]viz.ai
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the impact of Viz LVO in hospital systems with non-interventional and interventional (spoke and hub) stroke centers on the timing and outcomes of patients with suspected acute ischemic stroke indicated for mechanical thrombectomy.

Description:

This is a multi-center, non-randomized observational study of acute ischemic stroke patients whose CTA scans are analyzed by Viz LVO to support clinicians in making stroke triage decisions,. The study results will be compared to a cohort from enrolling centers prior to Viz LVO implementation that will serve as a historical control. Data will be collected retrospectively from the time of presentation through 90 days post discharge. The study will include patients undergoing imaging for a suspected LVO acute ischemic stroke. The post-Viz LVO intervention group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, following image analysis by Viz LVO. Data will be collected retrospectively on consecutive patients meeting eligibility criteria from the date of implementation up to 5 years post implementation. The control group will consist of patients who either presented to or underwent transfer to an interventional center, from a non-interventional center, for evaluation prior to the implementation of Viz LVO. Data will be collected on consecutive patients from one day prior to implementation, back as far as 2 years prior to implementation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 years or greater
• Signs and symptoms consistent with the diagnosis of a large vessel occlusive stroke
• Pre-treatment National Institutes of Health Stroke Scale (NIHSS) = 6
• Aspects Score =6
• Patient must have a suspected LVO in M1.
• Patient with an intention to treat with mechanical thrombectomy with confirmation of LVO by the CT/CTA radiographic report with the reading diagnosis.

Exclusion Criteria:

• Unable to undergo a brain imaging (i.e. severe contrast medium allergy, claustrophobia)

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

Intervention

Device:
• Viz LVO (De Novo Number DEN170073)
Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.

Locations

Country	Name	City	State
United States	Wellstar Neurosurgery	Atlanta	Georgia
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	Semmes-Murphey	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Viz.ai, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfer patients: Time from spoke CT/CTA to door-out	Time in minutes from CT/CTA imaging to time leaving the spoke center	up to 1 day (1440 minutes)
Primary	Non-transfer patients: Time from Hub door to groin puncture	Time in minutes from arrival a hub center to start time of treatment	up to 1 day (1440 minutes)
Secondary	Time from Spoke Door-In to Door-Out (DIDO)	Time in minutes from arrival at spoke hospital to departure to hub hospital	up to 1 day (1440 minutes)
Secondary	Time from Spoke CT/CTA to Specialist Notification	Time in minutes from CT/CTA imaging to time an interventionalist was notified	up to 1 day (1440 minutes)
Secondary	Time from Spoke CT/CTA to Groin Puncture	Time in minutes from CT/CTA imaging to start time of treatment	up to 1 day (1440 minutes)
Secondary	Time from Spoke Door to Groin Puncture	Time in minutes from departure to hub hospital to start time of treatment	up to 1 day (1440 minutes)
Secondary	Length of ICU Stay/Total Length of Stay	Number of days in hospital in the ICU and the total number of days in hospital	Hospital admit to discharge, up to 30 days
Secondary	Modified Rankin Scale (mRS) at Discharge and 90 Days	The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. A score of 0 is a patient with no residual symptoms. Scores increase with severity to 5 which equals severe disability.	90 days
Secondary	National Institutes of Health Stroke Scale (NIHSS) at Discharge	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity.	On date of discharge, up to 30 days
Secondary	Patient Disposition at Discharge and 90 Days	Data will be collected on whether or not the patient was discharged to their home or another type of care facility, and where they are located 90 days post hospital discharge	90 days