Stroke, IschemicNCT04608617
SYNCHRONISE: LVO Triage Timing and Outcome Study
An observational study of Stroke, Ischemic, run by Viz.ai, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Viz LVO (De Novo Number DEN170073) and Baseline Effectiveness Cohort
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Mar 2021to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected LVO acute ischemic stroke indicated for mechanical thrombectomy
Who may be able to join
- 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.
Who cannot join
- Unable to undergo a brain imaging (i.e. severe contrast medium allergy, claustrophobia)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wellstar Neurosurgery
Atlanta, Georgia, 30312
Valley Baptist Medical Center
Harlingen, Texas, 78550
Semmes-Murphey
Memphis, Tennessee, 38120
About this study
Official title: Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions- SYNCHRONISE
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.
Read the 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
- Conditions
- Stroke, Ischemic
- Being tested
- Viz LVO (De Novo Number DEN170073), Baseline Effectiveness Cohort
- Keywords
- Artificial Intelligence, Large Vessel Occlusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viz LVO (De Novo Number DEN170073)Device
Also called ContaCT
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.
Baseline Effectiveness CohortOther
No Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Viz | Pre-Viz LVO implementation patient data utilized as a control data set Receives: Other: Baseline Effectiveness Cohort | |
| Post-Viz | Patient data collected post-Viz LVO implementation Receives: Device: Viz LVO (De Novo Number DEN170073) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer patients: Time from spoke CT/CTA to door-out
Time in minutes from CT/CTA imaging to time leaving the spoke center
Measured: up to 1 day (1440 minutes)
Non-transfer patients: Time from Hub door to groin puncture
Time in minutes from arrival a hub center to start time of treatment
Measured: up to 1 day (1440 minutes)
Secondary outcomes (8)
Time from Spoke Door-In to Door-Out (DIDO)
Time in minutes from arrival at spoke hospital to departure to hub hospital
Measured: up to 1 day (1440 minutes)
Time from Spoke CT/CTA to Specialist Notification
Time in minutes from CT/CTA imaging to time an interventionalist was notified
Measured: up to 1 day (1440 minutes)
Time from Spoke CT/CTA to Groin Puncture
Time in minutes from CT/CTA imaging to start time of treatment
Measured: up to 1 day (1440 minutes)
Time from Spoke Door to Groin Puncture
Time in minutes from departure to hub hospital to start time of treatment
Measured: up to 1 day (1440 minutes)
Length of ICU Stay/Total Length of Stay
Number of days in hospital in the ICU and the total number of days in hospital
Measured: Hospital admit to discharge, up to 30 days
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.
Measured: 90 days
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.
Measured: On date of discharge, up to 30 days
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start9 Mar 2021
- Primary completion22 Feb 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viz.ai, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Thomas Devlin, Principal investigator, CHI MemorialDr. Ameer Hassan, Principal investigator, Valley Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608617
- Sponsor's protocol ID
- VIZ-LVO-03
- Status last verified
- Sep 2024
- First submitted
- 11 Oct 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions- SYNCHRONISE
- ClinicalTrials.gov ID
- NCT04608617
- Acronym / sponsor ID
- VIZ-LVO-03
- Conditions
- Stroke, Ischemic
- Keywords
- Artificial Intelligence, Large Vessel Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Viz.ai, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Viz | – | Other: Baseline Effectiveness CohortPre-Viz LVO implementation patient data utilized as a control data set |
| Post-Viz | – | Device: Viz LVO (De Novo Number DEN170073)Patient data collected post-Viz LVO implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected LVO acute ischemic stroke indicated for mechanical thrombectomy
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Unable to undergo a brain imaging (i.e. severe contrast medium allergy, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viz LVO (De Novo Number DEN170073)Also: ContaCTViz 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. | Device | Post-Viz |
| Baseline Effectiveness CohortNo Intervention was performed for the pre-Viz group. Record review to establish operational metrics only occurred. | Other | Pre-Viz |
Primary outcome
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
8 secondary outcomes
Time from Spoke Door-In to Door-Out (DIDO)
Time frame: up to 1 day (1440 minutes)
Time from Spoke CT/CTA to Specialist Notification
Time frame: up to 1 day (1440 minutes)
Time from Spoke CT/CTA to Groin Puncture
Time frame: up to 1 day (1440 minutes)
Time from Spoke Door to Groin Puncture
Time frame: up to 1 day (1440 minutes)
Length of ICU Stay/Total Length of Stay
Time frame: Hospital admit to discharge, up to 30 days
Modified Rankin Scale (mRS) at Discharge and 90 Days
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS) at Discharge
Time frame: On date of discharge, up to 30 days
Patient Disposition at Discharge and 90 Days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Thomas Devlin principal investigator
CHI Memorial
Dr. Ameer Hassan principal investigator
Valley Baptist
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Viz.ai, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfer patients: Time from spoke CT/CTA to door-out (time frame: up to 1 day (1440 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.