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Completed

NCT Number: NCT04608617

SYNCHRONISE: LVO Triage Timing and Outcome Study

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wellstar Neurosurgery, Atlanta, Georgia, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Viz LVO (De Novo Number DEN170073)

Device

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.

Other names: ContaCT

Baseline Effectiveness Cohort

Other

No Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred.

Primary outcomes

  1. 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

  2. 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

  1. Time from Spoke Door-In to Door-Out (DIDO)

    Time frame: up to 1 day (1440 minutes)

    Time in minutes from arrival at spoke hospital to departure to hub hospital

  2. Time from Spoke CT/CTA to Specialist Notification

    Time frame: up to 1 day (1440 minutes)

    Time in minutes from CT/CTA imaging to time an interventionalist was notified

  3. Time from Spoke CT/CTA to Groin Puncture

    Time frame: up to 1 day (1440 minutes)

    Time in minutes from CT/CTA imaging to start time of treatment

  4. Time from Spoke Door to Groin Puncture

    Time frame: up to 1 day (1440 minutes)

    Time in minutes from departure to hub hospital to start time of treatment

  5. Length of ICU Stay/Total Length of Stay

    Time frame: Hospital admit to discharge, up to 30 days

    Number of days in hospital in the ICU and the total number of days in hospital

  6. Modified Rankin Scale (mRS) at Discharge and 90 Days

    Time frame: 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.

  7. National Institutes of Health Stroke Scale (NIHSS) at Discharge

    Time frame: On date of discharge, up to 30 days

    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.

  8. Patient Disposition at Discharge and 90 Days

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Viz.ai, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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