Clinical trial NCT04608617: SYNCHRONISE: LVO Triage Timing and Outcome Study
Official title: Observational Study of Automated Detection for Identification, Triage, and Timely Intervention in Large Vessel Occlusions- SYNCHRONISE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Keywords: Artificial Intelligence
Large Vessel Occlusion
Lead sponsor: Viz.ai, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients, that meet eligibility criteria, undergoing imaging for a suspected LVO acute ischemic stroke indicated for mechanical thrombectomy

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

Eligibility criteria: 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)

Primary outcomes:
measure: Transfer patients: Time from spoke CT/CTA to door-out
timeFrame: up to 1 day (1440 minutes)
measure: Non-transfer patients: Time from Hub door to groin puncture
timeFrame: up to 1 day (1440 minutes)
Secondary outcomes:
measure: Time from Spoke Door-In to Door-Out (DIDO)
timeFrame: up to 1 day (1440 minutes)
measure: Time from Spoke CT/CTA to Specialist Notification
timeFrame: up to 1 day (1440 minutes)
measure: Time from Spoke CT/CTA to Groin Puncture
timeFrame: up to 1 day (1440 minutes)
measure: Time from Spoke Door to Groin Puncture
timeFrame: up to 1 day (1440 minutes)
measure: Length of ICU Stay/Total Length of Stay
timeFrame: Hospital admit to discharge, up to 30 days
measure: Modified Rankin Scale (mRS) at Discharge and 90 Days
timeFrame: 90 days
measure: National Institutes of Health Stroke Scale (NIHSS) at Discharge
timeFrame: On date of discharge, up to 30 days
measure: Patient Disposition at Discharge and 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Wellstar Neurosurgery
state: Georgia
city: Memphis
country: United States
facility: Semmes-Murphey
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
Study officials:
affiliation: CHI Memorial
name: Dr. Thomas Devlin
role: PRINCIPAL_INVESTIGATOR
affiliation: Valley Baptist
name: Dr. Ameer Hassan
role: PRINCIPAL_INVESTIGATOR
References: