Clinical trial NCT04142879: Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT)
Official title: Automated Detection and Triage of Large Vessel Occlusions Using Artificial Intelligence for Early and Rapid Treatment (ALERT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke Workflow and Clinical Outcome Parameters
Keywords: Large Vessel Occlusion
Lead sponsor: Providence Little Company of Mary-Torrance
Sponsor class: OTHER
Collaborators: name: Viz.ai, Inc.
First posted: 2019-10-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with an identified LVO per Viz will be eligible for the study.

Brief summary: Post Market, Prospective, Randomized, Controlled, multi center data collection study to evaluate the use of Viz versus the standard of care in stroke workflow and clinical outcome parameters.

Detailed description: This study will be a multicenter, multi arm, prospective randomized study to evaluate the use of Viz. The study will enroll all subjects that present at all participating centers that meet the study inclusion/exclusion during the period of study evaluation. All subject imaging (CT) data will be pushed to Viz and evaluated by Viz. Randomization will occur at the time of image processing by Viz that indicates the subject is positive for LVO per the software criteria (anterior location). Subjects randomized to the standard of care arm of the study will not receive any information via an automated notification from Viz. Subjects that are randomized to the Viz arm of the study will have an automated message sent to the enrolling center contacts. Subjects will be followed for 90 days post treatment. Data evaluation may occur at regular intervals throughout the study and at the completion of the study period.

Eligibility criteria: Inclusion Criteria:

A subject must meet all of the following inclusion criteria to be included in the study:

1. Age of 18 years or greater.
2. Signs and symptoms consistent with the diagnosis of a stroke.
3. Stroke protocol imaging (CTA) with a confirmed presence of anterior LVO via Viz.

Exclusion Criteria:

A subject may not be included in the study if any of the following exclusion criteria are met:

1. Poor or incomplete CTA imaging data.
2. Disagreement between neuroradiologist and stroke specialist or neurointerventionalist relative to presence of a stroke.
3. Other serious, advanced, or terminal illness (investigator judgment) requiring treatment that significantly delays initiating transfer and/or treatment for stroke.

Primary outcomes:
measure: Non-Interventional Centers
timeFrame: Time of subject presentation through up to 90 days post treatment.
measure: Interventional Centers
timeFrame: Time of subject presentation through up to 90 days post treatment.
Secondary outcomes:
measure: Workflow Endpoints
timeFrame: Time of subject presentation through up to 90 days post treatment.
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Providence Little Company of Mary Medical Center-Torrance
state: California
Study officials:
affiliation: Providence Little Company of Mary Medical Center-Torrance
name: Jason Tarpley, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Health & Services
name: Heliane Kauffman, B.S.N., R.N.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Khatri P, Yeatts SD, Mazighi M, Broderick JP, Liebeskind DS, Demchuk AM, Amarenco P, Carrozzella J, Spilker J, Foster LD, Goyal M, Hill MD, Palesch YY, Jauch EC, Haley EC, Vagal A, Tomsick TA; IMS III Trialists. Time to angiographic reperfusion and clinical outcome after acute ischaemic stroke: an analysis of data from the Interventional Management of Stroke (IMS III) phase 3 trial. Lancet Neurol. 2014 Jun;13(6):567-74. doi: 10.1016/S1474-4422(14)70066-3. Epub 2014 Apr 27.
citation: Goyal M, Jadhav AP, Bonafe A, Diener H, Mendes Pereira V, Levy E, Baxter B, Jovin T, Jahan R, Menon BK, Saver JL; SWIFT PRIME investigators. Analysis of Workflow and Time to Treatment and the Effects on Outcome in Endovascular Treatment of Acute Ischemic Stroke: Results from the SWIFT PRIME Randomized Controlled Trial. Radiology. 2016 Jun;279(3):888-97. doi: 10.1148/radiol.2016160204. Epub 2016 Apr 19.