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OpenTrials
Completed

NCT Number: NCT05838456

Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals

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.

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Key information

Conditions

Acute Ischemic Stroke (AIS) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Viz.AI software

Device

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

Primary outcomes

  1. 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 outcomes

  1. Number of Patients Who Received With Endovascular Stroke Therapy

    Time frame: at the time of initiation of endovascular stroke therapy

  2. 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.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 1, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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