Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07257146

Smart-SABI: Digital Phenotyping of Stroke Access Barriers

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria Stroke and Neurointervention Center

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Targeted Stroke Systems of Care Training (SABI-Guided)

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Predictive Accuracy of ML Model for "High-Risk" Delay

    Time frame: Baseline through Study Completion (12 months)

    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.

  2. Agreement between Subjective Transport Barriers and GIS Metrics

    Time frame: Baseline

    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.

  3. Functional Outcome (mRS) at 90 Days

    Time frame: 90 Days post-discharge

    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).

Sponsors and collaborators

Lead sponsor

Middle East North Africa Stroke and Interventional Neurotherapies Organization

Other

Registry information

Official study title

Machine Learning Identification of Modifiable Access Barriers in Acute Ischemic Stroke: A Multimodal "Digital Phenotyping" Approach

Acronym: Smart-SABI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

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.

Published trials that share one or more normalized conditions with this study.