Clinical trial NCT05838456: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke (AIS)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-05-01
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)
timeFrame: from the time of emergency room arrival to the time of initiation of endovascular stroke therapy (about 97 minutes)
Secondary outcomes:
measure: Number of Patients Who Received With Endovascular Stroke Therapy
timeFrame: at the time of initiation of endovascular stroke therapy
measure: Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2
timeFrame: 90 days
measure: Hospital Length of Stay
timeFrame: From the time of admission to the hospital to the time of discharge (about 7 days)
measure: Number of Patients With Intracranial Hemorrhage (ICH)
timeFrame: From the time of admission to the hospital to the time of discharge (about 7 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sunil Sheth, MD
role: PRINCIPAL_INVESTIGATOR
References: