Iniciativa BEAT STROKE de la OSM (BEAT STROKE)
WSO: Iniciativa Global para el Cerebro y el Corazón (BEAT)
The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice recommendations for secondary stroke prevention of cardioembolic strokes, as defined by the WSO Systematic Review and Synthesis of Global Stroke Guidelines or more recent high-quality evidence published after the last stroke guidelines1
Descripción general del estudio
Estado
Descripción detallada
The World Stroke Organization (WSO) Brain and Heart Task Force developed The Brain & hEart globAl iniTiative (BEAT), a pilot feasibility program aimed at establishing clinical collaborations between cardiologists and stroke physicians.1 The WSO BEAT pilot project focused on atrial fibrillation (AF) and patent foramen ovale (PFO) detection and management, highly prevalent cardioembolic causes of ischemic stroke and transient ischemic attack (TIA).
The pilot feasibility WSO BEAT program comprised 10 sites from 8 countries, including Brazil, China, Egypt, Germany, Japan, Mexico, Romania, and the USA. Of the 10 sites, two belonged exclusively to the public sector and one was public and private. The primary objective of the pilot WSO BEAT program was to assess its feasibility by achieving a composite feasibility outcome including: (1) developing site-specific clinical pathways for the diagnosis and management of AF, PFO, and the stroke heart syndrome; (2) establishing regular Neurocardiology rounds (e.g., monthly, bimonthly, etc.); and (3) incorporating a cardiologist to the stroke team.
Overall, the WSO BEAT program successfully achieved the pre-specified goals at most sites. Regarding the three primary program objectives, 9/10 (90%) of the sites were able to design or update the proposed clinical care pathways, establish Neurocardiology rounds, and designate a dedicated cardiologist for the stroke team, respectively.
To date it is unknown whether the implementation of Neurocardiology educational tools and collaborations between cardiologists and neurologists can improve adherence to best practice recommendations focused on the management of cardioembolic strokes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Diana Ayan, Pharm MSc
- Número de teléfono: 35826 519-685-8500
- Correo electrónico: diana.ayan@lhsc.on.ca
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6A 5A5
- Heart & Brain Lab, Western University
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Investigador principal:
- Luciano Sposato, MD, MBA
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Contacto:
- Jennifer Moussa
- Número de teléfono: 33110 519-685-8500
- Correo electrónico: jennifer.moussa@lhsc.on.ca
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Contacto:
- Diana Ayan, Pharm MSc
- Número de teléfono: 35826 519-685-8500
- Correo electrónico: diana.ayan@lhsc.on.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with ischemic stroke or TIA of any etiology.
Exclusion Criteria:
- N/A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: No intervention arm - Standard of Care for the institution
This group will not receive any of the educational and/or implementation Neurocardiology until the data collection is completed. |
Participants in the non-intervention arm will be followed for up to 12 months. Sites randomized to this arm will not receive any educational or implementation tools during the follow-up period. After the 12-month follow-up has been completed, sites may be provided with access to the Neurocardiology tool. |
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Comparador activo: Intervention arm - Educational and implementation Neurocardiology tool
Sites randomized in this arm will receive the educational and implementation Neurocardiology tool with the aim of improving adherence to best practice recommendations for secondary stroke prevention of cardioembolic strokes, as defined by the WSO Systematic Review and Synthesis of Global Stroke Guidelines or more recent high-quality evidence published after the last stroke guidelines. |
Sites randomized to the intervention arm will receive an educational and implementation-focused Neurocardiology tool designed to enhance adherence to best practice recommendations for secondary prevention of cardioembolic stroke. These recommendations are based on the World Stroke Organization (WSO) Systematic Review and Synthesis of Global Stroke Guidelines, supplemented by any high-quality evidence published after the most recent stroke guidelines. In addition, participating sites will be provided with 14-day Holter monitors for all patients enrolled in the study. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score
Periodo de tiempo: 6-months
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Difference between baseline and 6-month mean World Stroke Organization Brain and Heart global Initiative Stroke (WSO BEAT-STROKE) Evaluation for Adherence to Treatment Neurocardiology Score Description: The WSO BEAT-STROKE Neurocardiology Score is a composite scale used to measure adherence to best practice recommendations for the secondary prevention of cardioembolic stroke. It is composed of 8 categories (initial workup, stroke-heart syndrome, ESUS workup, patent foramen ovale, atrial fibrillation management, etc.) with a weighted scoring system (see Table 1). Scale range: 0 (no adherence) to 10 (full adherence). Interpretation: Higher scores indicate greater adherence to guideline-recommended care. Calculation: Each patient's score is calculated by dividing the total points achieved by the total possible points for which the patient is eligible, as not all patients qualify for ESUS, PFO, or AF items. |
6-months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score for each of the 5 pre-specified cathegories.
Periodo de tiempo: 6-months
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Difference between baseline and 6-month mean World Stroke Organization Brain and Heart global Initiative Stroke (WSO BEAT-STROKE) Evaluation for Adherence to Treatment Neurocardiology Score by category Description: This outcome evaluates adherence to best practice recommendations within each of five pre-specified categories of the WSO BEAT-STROKE Neurocardiology Score:
Scale range: 0 (no adherence) to 10 (full adherence). Interpretation: Higher scores indicate greater adherence to guideline-recommended care. Calculation: Each patient's category score is calculated as the sum of points achieved within that category divided by the maximum possible points for which the patient is eligible. |
6-months
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Long-term achievement of the primary outcome at 12 months.
Periodo de tiempo: 12-months
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Long-term difference between baseline and 12-month mean World Stroke Organization Brain and Heart global Initiative Stroke (WSO BEAT-STROKE) Evaluation for Adherence to Treatment Neurocardiology Score Description: This outcome assesses the long-term change in adherence to guideline-recommended care, measured using the WSO BEAT-STROKE Neurocardiology Score. The score incorporates 8 weighted categories (e.g., initial workup, stroke-heart syndrome, ESUS workup, PFO, and AF management). Scale range: 0 (no adherence) to 10 (full adherence). Interpretation: Higher scores indicate greater adherence to best practice recommendations. Calculation: Each patient's score is calculated as the sum of points achieved divided by the total possible points for which the patient is eligible, as not all patients qualify for ESUS, PFO, or AF items. Time Frame: 12 months |
12-months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exploratory endpoint. Major adverse cardiovascular events (MACE) at 12 months
Periodo de tiempo: 12-months
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Major adverse cardiovascular events (MACE) at 12 months are defined as the composite of the following events:
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12-months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Arritmias Cardiacas
- Anomalías congénitas
- Anomalías cardiovasculares
- Defectos Cardíacos Congénitos
- Defectos del tabique cardíaco, auricular
- Defectos del tabique cardíaco
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Carrera
- Fibrilación auricular
- Foramen oval permeable
Otros números de identificación del estudio
- 14852
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Upon reasonable request and after the Approval of Western University Ethics Review Board
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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