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Набор по приглашению NCT07257146

Smart-SABI: Digital Phenotyping of Stroke Access Barriers

— Наблюдательное Stroke Practice Healthcare Disparities Thrombectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Targeted Stroke Systems of Care Training (SABI-Guided).
Кому может быть актуально
Состояния в реестре: Stroke, Practice, Healthcare Disparities, Thrombectomy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 SAB

Первичные конечные точки

  • Correlation of SABI Score with Infarct Core Volume (The Biological Anchor) [Срок оценки: Baseline (Admission Imaging)]
Вторичные конечные точки (3)
  • Predictive Accuracy of ML Model for "High-Risk" Delay [Срок оценки: Baseline through Study Completion (12 months)]
  • Agreement between Subjective Transport Barriers and GIS Metrics [Срок оценки: Baseline]
  • Functional Outcome (mRS) at 90 Days [Срок оценки: 90 Days post-discharge]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Alexandria Stroke and Neurointervention Center — Alexandria

Идентификаторы

NCT: NCT07257146 · MENASINO105 · NALAregistrySABI2026

Первоисточники (государственные реестры)

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