Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

June 3, 2023 updated by: Sunil A. Sheth, The University of Texas Health Science Center, Houston

After onset of Acute Ischemic Stroke (AIS), every minute of delay to treatment reduces the likelihood of a good clinical outcome. A key delay occurs in the time between completion of computed tomography (CT) angiography of the head and neck and interpretation in the setting of AIS care.

The purpose of this study is to assess the effect of incorporating Viz.AI software, which via via a machine-learning algorithm performs artificial intelligence-based automated detection of large vessel occlusions (LVO) on CT angiography (CTA) images and alerts the AIS care team (diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, per routine standard of care). The hypothesis is that integration of the software into the AIS care pathway will reduce delays in treatment. A cluster-randomized stepped-wedge trial will be performed across 4 hospitals in the greater Houston area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

443

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or Female
  • 18 years of age or older.
  • Patients who present to the emergency department with signs and/or symptoms concerning for acute ischemic stroke.
  • Patients who undergo CT angiography imaging
  • Patients determined to have a large vessel occlusion acute ischemic stroke. This determination will be made based on official radiology report for the CT angiography imaging.

Exclusion Criteria:

  • Patients with incomplete data on the electronic medical record.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hospital 1 - 3 months with no Viz.AI software, then 12 months with Viz.AI software
Device: Viz.AI software
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.
Experimental: Hospital 2 - 6 months with no Viz.AI software, then 9 months with Viz.AI software
Device: Viz.AI software
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.
Experimental: Hospital 3 - 9 months with no Viz.AI software, then 6 months with Viz.AI software
Device: Viz.AI software
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.
Experimental: Hospital 4 - 12 months with no Viz.AI software, then 3 months with Viz.AI software
Device: Viz.AI software
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)
Time Frame: from the time of emergency room arrival to the time of initiation of endovascular stroke therapy (about 97 minutes)
from the time of emergency room arrival to the time of initiation of endovascular stroke therapy (about 97 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: From the time of admission to the hospital to the time of discharge (about 7 days)
The number of days of inpatient hospitalization.
From the time of admission to the hospital to the time of discharge (about 7 days)
Number of Patients Who Received With Endovascular Stroke Therapy
Time Frame: at the time of initiation of endovascular stroke therapy
at the time of initiation of endovascular stroke therapy
Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2
Time Frame: 90 days
The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scales ranges from 0-6, as follows: 0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.
90 days
Number of Patients With Intracranial Hemorrhage (ICH)
Time Frame: From the time of admission to the hospital to the time of discharge (about 7 days)
Number of participants with any intracranial hemorrhage (ICH) and symptomatic ICH (Defined by ECASS II criteria)
From the time of admission to the hospital to the time of discharge (about 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Sunil Sheth, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

May 27, 2022

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-19-0630
  • UL1TR003167 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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