Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

Acute Ischemic Stroke (AIS) Clinical Trial

Official title:

Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838456
• Other study ID #: HSC-MS-19-0630
• Secondary ID: UL1TR003167
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 27, 2022

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: May 27, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke (AIS)
• Ischemic Stroke
• Stroke

Intervention

Device:
• Viz.AI software
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)		from the time of emergency room arrival to the time of initiation of endovascular stroke therapy (about 97 minutes)
Secondary	Number of Patients Who Received With Endovascular Stroke Therapy		at the time of initiation of endovascular stroke therapy
Secondary	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.	90 days
Secondary	Hospital Length of Stay	The number of days of inpatient hospitalization.	From the time of admission to the hospital to the time of discharge (about 7 days)
Secondary	Number of Patients With Intracranial Hemorrhage (ICH)	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)