An observational study in Stroke, Practice and Healthcare Disparities, sponsored by Middle East North Africa Stroke and Interventional Neurotherapies Organization. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Middle East North Africa Stroke and Interventional Neurotherapies Organization · Observational
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 250 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Middle East North Africa Stroke and Interventional Neurotherapies Organization is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient or Legally Authorized Representative (LAR) able to provide .
Verifiable residential address (required for GIS analysis).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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).
Time frame: Baseline (Admission Imaging)
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.
Time frame: 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.
Time frame: 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).
Time frame: 90 Days post-discharge
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Feb 2027, 16 months after the start.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 16 months is below that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
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Middle East North Africa Stroke and Interventional Neurotherapies Organization