Acute Ischemic Stroke (AIS)NCT05838456
Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals
A study testing Viz.AI software in people with Acute Ischemic Stroke (AIS), run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke (AIS)
- What is being tested?
- Viz.AI software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 27 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with incomplete data on the electronic medical record.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Acute Ischemic Stroke (AIS)
- Being tested
- Viz.AI software
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viz.AI softwareDevice
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.
| Study group | Role | What they receive |
|---|---|---|
| Hospital 1 - 3 months with no Viz.AI software, then 12 months with Viz.AI software | Experimental | Not described Receives: Device: Viz.AI software |
| Hospital 2 - 6 months with no Viz.AI software, then 9 months with Viz.AI software | Experimental | Not described Receives: Device: Viz.AI software |
| Hospital 3 - 9 months with no Viz.AI software, then 6 months with Viz.AI software | Experimental | Not described Receives: Device: Viz.AI software |
| Hospital 4 - 12 months with no Viz.AI software, then 3 months with Viz.AI software | Experimental | Not described Receives: Device: Viz.AI software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy ("Door-to-groin" Time)
Measured: from the time of emergency room arrival to the time of initiation of endovascular stroke therapy (about 97 minutes)
Secondary outcomes (4)
Number of Patients Who Received With Endovascular Stroke Therapy
Measured: 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
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.
Measured: 90 days
Hospital Length of Stay
The number of days of inpatient hospitalization.
Measured: From the time of admission to the hospital to the time of discharge (about 7 days)
Number of Patients With Intracranial Hemorrhage (ICH)
Number of participants with any intracranial hemorrhage (ICH) and symptomatic ICH (Defined by ECASS II criteria)
Measured: From the time of admission to the hospital to the time of discharge (about 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jan 2021
- Primary completion28 Feb 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Sunil A. Sheth, The University of Texas Health Science Center, Houston
- Investigators
- Sunil Sheth, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838456
- Sponsor's protocol ID
- HSC-MS-19-0630
- Other IDs
- UL1TR003167
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2023
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Martinez-Gutierrez JC, Kim Y, Salazar-Marioni S, Tariq MB, Abdelkhaleq R, Niktabe A, Ballekere AN, Iyyangar AS, Le M, Azeem H, Miller CC, Tyson JE, Shaw S, Smith P, Cowan M, Gonzales I, McCullough LD, Barreto AD, Giancardo L, Sheth SA. Automated Large Vessel Occlusion Detection Software and Thrombectomy Treatment Times: A Cluster Randomized Clinical Trial. JAMA Neurol. 2023 Nov 1;80(11):1182-1190. doi: 10.1001/jamaneurol.2023.3206.
PubMed 37721738
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning Enabled Endovascular Stroke Therapy Screening in Community Hospitals
- ClinicalTrials.gov ID
- NCT05838456
- Acronym / sponsor ID
- HSC-MS-19-0630
- Conditions
- Acute Ischemic Stroke (AIS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hospital 1 - 3 months with no Viz.AI software, then 12 months with Viz.AI software | Experimental | Device: Viz.AI software |
| Hospital 2 - 6 months with no Viz.AI software, then 9 months with Viz.AI software | Experimental | Device: Viz.AI software |
| Hospital 3 - 9 months with no Viz.AI software, then 6 months with Viz.AI software | Experimental | Device: Viz.AI software |
| Hospital 4 - 12 months with no Viz.AI software, then 3 months with Viz.AI software | Experimental | Device: Viz.AI software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with incomplete data on the electronic medical record.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viz.AI softwareViz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team. | Device | 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 |
Primary outcome
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)
4 secondary outcomes
Number of Patients Who Received With Endovascular Stroke Therapy
Time frame: 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
Hospital Length of Stay
Time frame: From the time of admission to the hospital to the time of discharge (about 7 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37721738Martinez-Gutierrez JC, Kim Y, Salazar-Marioni S, Tariq MB, Abdelkhaleq R, Niktabe A, Ballekere AN, Iyyangar AS, Le M, Azeem H, Miller CC, Tyson JE, Shaw S, Smith P, Cowan M, Gonzales I, McCullough LD, Barreto AD, Giancardo L, Sheth SA. Automated Large Vessel Occlusion Detection Software and Thrombectomy Treatment Times: A Cluster Randomized Clinical Trial. JAMA Neurol. 2023 Nov 1;80(11):1182-1190. doi: 10.1001/jamaneurol.2023.3206.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Sheth, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viz.AI software in people with Acute Ischemic Stroke (AIS), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.