Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions- SYNCHRONISE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Viz.ai, Inc.
- Enrollment
- 1,000
- Locations
- 3
- Primary Endpoint
- Transfer patients: Time from spoke CT/CTA to door-out
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 M
- •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)
Outcomes
Primary Outcomes
Transfer patients: Time from spoke CT/CTA to door-out
Time Frame: up to 1 day (1440 minutes)
Time in minutes from CT/CTA imaging to time leaving the spoke center
Non-transfer patients: Time from Hub door to groin puncture
Time Frame: up to 1 day (1440 minutes)
Time in minutes from arrival a hub center to start time of treatment
Secondary Outcomes
- Time from Spoke Door to Groin Puncture(up to 1 day (1440 minutes))
- Length of ICU Stay/Total Length of Stay(Hospital admit to discharge, up to 30 days)
- Modified Rankin Scale (mRS) at Discharge and 90 Days(90 days)
- Time from Spoke Door-In to Door-Out (DIDO)(up to 1 day (1440 minutes))
- Time from Spoke CT/CTA to Groin Puncture(up to 1 day (1440 minutes))
- Time from Spoke CT/CTA to Specialist Notification(up to 1 day (1440 minutes))
- National Institutes of Health Stroke Scale (NIHSS) at Discharge(On date of discharge, up to 30 days)
- Patient Disposition at Discharge and 90 Days(90 days)