StrokeSmart-SABINCT07257146
Smart-SABI: Digital Phenotyping of Stroke Access Barriers
An observational study of Stroke and Practice, run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 1 site in Egypt.
Trial summary
This study aims to identify and quantify the non-clinical barriers (social, transport, and knowledge-based) that delay patient arrival at the hospital during an Acute Ischemic Stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Practice, Healthcare Disparities
- What is being tested?
- Targeted Stroke Systems of Care Training (SABI-Guided)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2025to 11 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The source population comprises patients recruited from 12 tertiary centers across the MENA region: Alexandria University, Ain Shams University, and Cairo University (Egypt); Eskisehir Osmangazi University and Dr. Lutfi Kirdar City Hospital (Turkey); Amman Specialized IR Center (Jordan); King Khalid University, King Abdullah Medical City, and Imam Abdulrahman Al Faisal University (Saudi Arabia); Institute National de Neurology (Tunisia); Cleveland Clinic Abu Dhabi (UAE); and Weill Cornell Medicine (Qatar). This multinational design ensures significant geographic heterogeneity-ranging from the dense urban traffic of Istanbul and Cairo to the mountainous terrain of Abha-which is critical for GIS transport analysis. Additionally, the inclusion of diverse economic and cultural backgrounds supports robust SABI analysis regarding stroke awareness and health-seeking behaviors across the region.
Who may be able to join
- Diagnosis of Acute Ischemic Stroke (AIS) confirmed by neuroimaging (CT or MRI). Age $\geq$ 18 years. Presentation to the Emergency Department within 7 days of symptom onset (to ensure recall accuracy).
- Patient or Legally Authorized Representative (LAR) able to provide informed consent.
- Verifiable residential address (required for GIS analysis).
Who cannot join
- In-hospital stroke onset. Stroke mimics (e.g., seizure, complex migraine, hypoglycemia). Hemorrhagic stroke. Homelessness or lack of fixed address (precludes geospatial analysis). Severe aphasia or cognitive deficit without an available surrogate/caregiver to complete the questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Machine Learning Identification of Modifiable Access Barriers in Acute Ischemic Stroke: A Multimodal "Digital Phenotyping" Approach
This study aims to identify and quantify the non-clinical barriers (social, transport, and knowledge-based) that delay patient arrival at the hospital during an Acute Ischemic Stroke. By utilizing a multimodal approach that combines a validated patient questionnaire (SABI Tool), Geographic Information Systems (GIS) analysis, and biological markers (infarct volume), the investigators seek to develop a Machine Learning model capable of predicting high-risk phenotypes for pre-hospital delay. The ultimate goal is to validate "Social Determinants of Health" against objective biological outcomes.
Read the detailed description
Despite advances in stroke reperfusion therapies (thrombectomy and thrombolysis), pre-hospital delays remain the primary cause of preventable disability. Current triage systems rely heavily on clinical severity scales but fail to account for Social Determinants of Health (SDOH) that dictate onset-to-door times.
This is a prospective, observational, single-center cohort study designed to validate the "Stroke Access Barrier Identification" (SABI) tool using a "Triangulation Strategy."
The study employs three distinct data sources:
Subjective: Administration of the SABI questionnaire to assess cognitive, physical, and structural barriers.
Geospatial (Objective): Network-based GIS analysis to calculate precise drive-time isochrones and public transit density, validating patient reports of transport difficulty.
Biological (The "Anchor"): Correlation of barrier scores with Infarct Core Volume (measured via CT-Perfusion/MRI) and 90-day functional outcomes.
Data will be processed using interpretable Machine Learning algorithms (Random Forest / XGBoost) and SHAP (SHapley Additive exPlanations) values to identify the specific social features that most strongly predict delayed presentation and increased brain tissue loss.
- Conditions
- Stroke, Practice, Healthcare Disparities, Thrombectomy, Healthcare Access
- Being tested
- Targeted Stroke Systems of Care Training (SABI-Guided)
- Keywords
- thrombectomy access, SABI, Stroke Access Barriers Index
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Stroke Systems of Care Training (SABI-Guided)Behavioural
Implementation of targeted barrier-reduction strategies at selected stroke centers based on baseline SABI profiles. The primary intervention consists of EMS Training Programs focused on stroke recognition, triage protocols, and rapid transport to Mechanical Thrombectomy (MT) capable centers.
Comparator/Control: Pre-intervention period (historical control) where standard of care was utilized without the targeted SABI-guided training.
Post-Intervention: Assessment of MT utilization rates and SABI scores following the implementation of the training modules.
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients | Acute Ischemic Stroke (AIS) Patients This cohort consists of adult patients presenting to the Emergency Department with a confirmed clinical and radiological diagnosis of Acute Ischemic Stroke. The group encompasses a continuous spectrum of arrival times, subsequently stratified during analysis into "Early Arrivers" (presenting within the therapeutic window, typically < 4.5 hours) and "Late Arrivers" (presenting after the therapeutic window). Receives: Behavioral: Targeted Stroke Systems of Care Training (SABI-Guided) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SABI Score with Infarct Core Volume (The Biological Anchor)
To validate if subjective barriers correlate with objective physiological damage. The total score on the SABI questionnaire (Scale 0-100, higher scores indicate higher barriers) will be correlated with the admission Infarct Core Volume (measured in milliliters via automated CT-Perfusion software).
Measured: Baseline (Admission Imaging)
Secondary outcomes (3)
Predictive Accuracy of ML Model for "High-Risk" Delay
Sensitivity and Specificity of the XGBoost Machine Learning model in classifying patients as "Early Arrivers" vs. "Late Arrivers" (defined as >4.5 hours from Last Known Well) using combined clinical and SABI variables.
Measured: Baseline through Study Completion (12 months)
Agreement between Subjective Transport Barriers and GIS Metrics
Cohen's Kappa coefficient measuring agreement between patient-reported "Difficulty with Transport" (SABI Domain 2) and objective "Network Drive Time" calculated via ArcGIS using historical traffic data.
Measured: Baseline
Functional Outcome (mRS) at 90 Days
Correlation between baseline SABI Barrier Score and the Modified Rankin Scale (mRS) score at 90 days. The mRS is a scale from 0 (no symptoms) to 6 (dead).
Measured: 90 Days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start11 Oct 2025
- Primary completion11 Feb 2027 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ossama Mansour, Middle East North Africa Stroke and Interventional Neurotherapies Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257146
- Sponsor's protocol ID
- MENASINO105
- Other IDs
- NALAregistrySABI2026
- Acronym
- Smart-SABI
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Identification of Modifiable Access Barriers in Acute Ischemic Stroke: A Multimodal "Digital Phenotyping" Approach
- ClinicalTrials.gov ID
- NCT07257146
- Acronym / sponsor ID
- Smart-SABI / MENASINO105
- Conditions
- Stroke, Practice, Healthcare Disparities, Thrombectomy, Healthcare Access
- Keywords
- thrombectomy access, SABI, Stroke Access Barriers Index
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies OrganizationUniversity, hospital or other
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify and quantify the non-clinical barriers (social, transport, and knowledge-based) that delay patient arrival at the hospital during an Acute Ischemic Stroke. By utilizing a multimodal approach that combines a validated patient questionnaire (SABI Tool), Geographic Information Systems (GIS) analysis, and biological markers (infarct volume), the investigators seek to develop a Machine Learning model capable of predicting high-risk phenotypes for pre-hospital delay. The ultimate goal is to validate "Social Determinants of Health" against objective biological outcomes.
Detailed description
Despite advances in stroke reperfusion therapies (thrombectomy and thrombolysis), pre-hospital delays remain the primary cause of preventable disability. Current triage systems rely heavily on clinical severity scales but fail to account for Social Determinants of Health (SDOH) that dictate onset-to-door times.
This is a prospective, observational, single-center cohort study designed to validate the "Stroke Access Barrier Identification" (SABI) tool using a "Triangulation Strategy."
The study employs three distinct data sources:
Subjective: Administration of the SABI questionnaire to assess cognitive, physical, and structural barriers.
Geospatial (Objective): Network-based GIS analysis to calculate precise drive-time isochrones and public transit density, validating patient reports of transport difficulty.
Biological (The "Anchor"): Correlation of barrier scores with Infarct Core Volume (measured via CT-Perfusion/MRI) and 90-day functional outcomes.
Data will be processed using interpretable Machine Learning algorithms (Random Forest / XGBoost) and SHAP (SHapley Additive exPlanations) values to identify the specific social features that most strongly predict delayed presentation and increased brain tissue loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients | – | Behavioral: Targeted Stroke Systems of Care Training (SABI-Guided)Acute Ischemic Stroke (AIS) Patients This cohort consists of adult patients presenting to the Emergency Department with a confirmed clinical and radiological diagnosis of Acute Ischemic Stroke. The group encompasses a continuous spectrum of arrival times, subsequently stratified during analysis into "Early Arrivers" (presenting within the therapeutic window, typically < 4.5 hours) and "Late Arrivers" (presenting after the therapeutic window). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The source population comprises patients recruited from 12 tertiary centers across the MENA region: Alexandria University, Ain Shams University, and Cairo University (Egypt); Eskisehir Osmangazi University and Dr. Lutfi Kirdar City Hospital (Turkey); Amman Specialized IR Center (Jordan); King Khalid University, King Abdullah Medical City, and Imam Abdulrahman Al Faisal University (Saudi Arabia); Institute National de Neurology (Tunisia); Cleveland Clinic Abu Dhabi (UAE); and Weill Cornell Medicine (Qatar). This multinational design ensures significant geographic heterogeneity-ranging from the dense urban traffic of Istanbul and Cairo to the mountainous terrain of Abha-which is critical for GIS transport analysis. Additionally, the inclusion of diverse economic and cultural backgrounds supports robust SABI analysis regarding stroke awareness and health-seeking behaviors across the region.
Key inclusion criteria (3 listed)
- Diagnosis of Acute Ischemic Stroke (AIS) confirmed by neuroimaging (CT or MRI). Age $\geq$ 18 years. Presentation to the Emergency Department within 7 days of symptom onset (to ensure recall accuracy).
- Patient or Legally Authorized Representative (LAR) able to provide informed consent.
- Verifiable residential address (required for GIS analysis).
Key exclusion criteria (1 listed)
- In-hospital stroke onset. Stroke mimics (e.g., seizure, complex migraine, hypoglycemia). Hemorrhagic stroke. Homelessness or lack of fixed address (precludes geospatial analysis). Severe aphasia or cognitive deficit without an available surrogate/caregiver to complete the questionnaire.
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 |
|---|---|---|
| Targeted Stroke Systems of Care Training (SABI-Guided)Implementation of targeted barrier-reduction strategies at selected stroke centers based on baseline SABI profiles. The primary intervention consists of EMS Training Programs focused on stroke recognition, triage protocols, and rapid transport to Mechanical Thrombectomy (MT) capable centers. Comparator/Control: Pre-intervention period (historical control) where standard of care was utilized without the targeted SABI-guided training. Post-Intervention: Assessment of MT utilization rates and SABI scores following the implementation of the training modules. | Behavioural | Acute Ischemic Stroke (AIS) Patients |
Primary outcome
Correlation of SABI Score with Infarct Core Volume (The Biological Anchor)
Time frame: Baseline (Admission Imaging)
To validate if subjective barriers correlate with objective physiological damage. The total score on the SABI questionnaire (Scale 0-100, higher scores indicate higher barriers) will be correlated with the admission Infarct Core Volume (measured in milliliters via automated CT-Perfusion software).
3 secondary outcomes
Predictive Accuracy of ML Model for "High-Risk" Delay
Time frame: Baseline through Study Completion (12 months)
Agreement between Subjective Transport Barriers and GIS Metrics
Time frame: Baseline
Functional Outcome (mRS) at 90 Days
Time frame: 90 Days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Practice, run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 1 site in Egypt.
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 3 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: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation of SABI Score with Infarct Core Volume (The Biological Anchor) (time frame: Baseline (Admission Imaging)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.