Acute Ischemic Stroke (AIS)
Conditions
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.
Interventions
DEVICEViz.AI software
Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Received With Endovascular Stroke Therapy | 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 | 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. |
| Hospital Length of Stay | From the time of admission to the hospital to the time of discharge (about 7 days) | The number of days of inpatient hospitalization. |
| Number of Patients With Intracranial Hemorrhage (ICH) | 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) |
Countries
United States
Participant flow
Pre-assignment details
443 were enrolled, but 200 were excluded before assignment to groups. 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). Each participant was only part of the study for one single period, in other words, participants did not progress to future periods.
Participants by arm
| Arm | Count |
|---|---|
| no Viz.AI Software Time before Viz.AI software was implemented | 140 |
| With Viz.AI Software Time after Viz.AI software was implemented. Viz.AI software performs artificial intelligence-based automated detection of large vessel occlusions and alerts the AIS care team. | 103 |
| Total | 243 |
Baseline characteristics
| Characteristic | no Viz.AI Software | With Viz.AI Software | Total |
|---|---|---|---|
| Age, Continuous | 69.5 years | 71 years | 70 years |
| Number of participants who received intravenous tissue plasminogen activator (tPA) | 63 Participants | 48 Participants | 111 Participants |
| Number of participants with atrial fibrillation | 41 Participants | 30 Participants | 71 Participants |
| Number of participants with congestive heart failure | 15 Participants | 12 Participants | 27 Participants |
| Number of participants with diabetes | 46 Participants | 23 Participants | 69 Participants |
| Number of participants with history of smoking | 28 Participants | 23 Participants | 51 Participants |
| Number of participants with hyperlipidemia | 55 Participants | 33 Participants | 88 Participants |
| Number of Participants with hypertension | 107 Participants | 75 Participants | 182 Participants |
| Number of participants with prior stroke | 24 Participants | 19 Participants | 43 Participants |
| Number of participants with prior transient ischemic attack (TIA) | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Black | 42 Participants | 27 Participants | 69 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Hispanic | 25 Participants | 16 Participants | 41 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Other | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Race and Ethnicity White | 58 Participants | 50 Participants | 108 Participants |
| Region of Enrollment United States | 140 Participants | 103 Participants | 243 Participants |
| Score on the Alberta stroke program early CT score (ASPECTS) | 9 score on a scale | 10 score on a scale | 9 score on a scale |
| Score on the NIH Stroke Scale (NIHSS) | 17 score on a scale | 16 score on a scale | 17 score on a scale |
| Sex: Female, Male Female | 73 Participants | 49 Participants | 122 Participants |
| Sex: Female, Male Male | 67 Participants | 54 Participants | 121 Participants |
| Time from last known well to time of hospital arrival | 131.5 minutes | 147 minutes | 132 minutes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 44 / 140 | 13 / 103 |
| other Total, other adverse events | 17 / 140 | 17 / 103 |
| serious Total, serious adverse events | 7 / 140 | 2 / 103 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Viz.AI Software | Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy (Door-to-groin Time) | 100 minutes |
| With Viz.AI Software | Time From Emergency Room Arrival to Initiation of Endovascular Stroke Therapy (Door-to-groin Time) | 88 minutes |
Secondary
Hospital Length of Stay
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| no Viz.AI Software | Hospital Length of Stay | 7 days |
| With Viz.AI Software | Hospital Length of Stay | 6 days |
Secondary
Number of Patients Who Received With Endovascular Stroke Therapy
Time frame: at the time of initiation of endovascular stroke therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| no Viz.AI Software | Number of Patients Who Received With Endovascular Stroke Therapy | 140 Participants |
| With Viz.AI Software | Number of Patients Who Received With Endovascular Stroke Therapy | 103 Participants |
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.
Time frame: 90 days
Population: mRS data were not collected for 50 in the no Viz.AI software arm and 79 in the with Viz.AI software arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| no Viz.AI Software | Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2 | 29 Participants |
| With Viz.AI Software | Number of Patients With Good Functional Outcome Defined as Modified Rankin Score (mRS) of 0-2 | 10 Participants |
Secondary
Number of Patients With Intracranial Hemorrhage (ICH)
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| no Viz.AI Software | Number of Patients With Intracranial Hemorrhage (ICH) | Non-Symptomatic ICH | 17 Participants |
| no Viz.AI Software | Number of Patients With Intracranial Hemorrhage (ICH) | Symptomatic ICH | 7 Participants |
| With Viz.AI Software | Number of Patients With Intracranial Hemorrhage (ICH) | Non-Symptomatic ICH | 17 Participants |
| With Viz.AI Software | Number of Patients With Intracranial Hemorrhage (ICH) | Symptomatic ICH | 2 Participants |