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Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

Primary Purpose

Acute Ischemic Stroke (AIS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viz.AI software
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Ischemic Stroke (AIS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Hospital 1 - 3 months with no Viz.AI software, then 12 months with Viz.AI software

Hospital 2 - 6 months with no Viz.AI software, then 9 months with Viz.AI software

Hospital 3 - 9 months with no Viz.AI software, then 6 months with Viz.AI software

Hospital 4 - 12 months with no Viz.AI software, then 3 months with Viz.AI software

Arm Description

Outcomes

Primary Outcome Measures

Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)

Secondary Outcome Measures

Number of Patients Who Received With Endovascular Stroke Therapy
Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2
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.
Hospital Length of Stay
The number of days of inpatient hospitalization.
Number of Patients With Intracranial Hemorrhage (ICH)
Number of participants with any intracranial hemorrhage (ICH) and symptomatic ICH (Defined by ECASS II criteria)

Full Information

First Posted
April 17, 2023
Last Updated
June 3, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05838456
Brief Title
Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals
Official Title
Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke (AIS)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a stepped wedge cluster-randomized trial with 4 clusters (4 different hospitals). In a stepped wedge fashion over 3 month intervals, the 4 clusters will initiate use of the software package (Viz.AI). The order of implementation of the Viz.AI software at the four hospitals will be randomly determined.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital 1 - 3 months with no Viz.AI software, then 12 months with Viz.AI software
Arm Type
Experimental
Arm Title
Hospital 2 - 6 months with no Viz.AI software, then 9 months with Viz.AI software
Arm Type
Experimental
Arm Title
Hospital 3 - 9 months with no Viz.AI software, then 6 months with Viz.AI software
Arm Type
Experimental
Arm Title
Hospital 4 - 12 months with no Viz.AI software, then 3 months with Viz.AI software
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Viz.AI software
Intervention Description
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Number of Patients Who Received With Endovascular Stroke Therapy
Time Frame
at the time of initiation of endovascular stroke therapy
Title
Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2
Description
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.
Time Frame
90 days
Title
Hospital Length of Stay
Description
The number of days of inpatient hospitalization.
Time Frame
From the time of admission to the hospital to the time of discharge (about 7 days)
Title
Number of Patients With Intracranial Hemorrhage (ICH)
Description
Number of participants with any intracranial hemorrhage (ICH) and symptomatic ICH (Defined by ECASS II criteria)
Time Frame
From the time of admission to the hospital to the time of discharge (about 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Sheth, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

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