Smart-SABI: Digital Phenotyping of Stroke Access Barriers

NCT07257146 | Enrolling By Invitation

• 2 other identifiers: MENASINO105NALAregistrySABI2026
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Practice; Healthcare Disparities; Thrombectomy; Healthcare Access

Keywords

thrombectomy access; SABI; Stroke Access Barriers Index

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (Admission Imaging)

Secondary Outcomes (3)

• Predictive Accuracy of ML Model for "High-Risk" Delay

  Baseline through Study Completion (12 months)

• Agreement between Subjective Transport Barriers and GIS Metrics

  Baseline

• Functional Outcome (mRS) at 90 Days

  90 Days post-discharge

Study Arms (1)

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).

Behavioral: Targeted Stroke Systems of Care Training (SABI-Guided)

Interventions

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.

Acute Ischemic Stroke (AIS) Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Middle East North Africa Stroke and Interventional Neurotherapies Organization: lead

Study Sites (1)

Alexandria Stroke and Neurointervention Center

Alexandria, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Neurology and Neuroradiology Alexandria university

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: October 11, 2025
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): April 11, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

EG (1)