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Initiative BEAT STROKE du WSO (BEAT STROKE)

15 septembre 2026 mis à jour par: Luciano A. Sposato

WSO - L'AVC Brain and HEart Global IniTiative (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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

2400

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Heart & Brain Lab, Western University
        • Chercheur principal:
          • Luciano Sposato, MD, MBA
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients with ischemic stroke or TIA of any etiology.

Exclusion Criteria:

  • N/A

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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.
Autre: No educational or implementation tool will be provided

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.
Comparateur actif: 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.
Autre: Educational and implementation Neurocardiology tool

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score
Délai: 6-months

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score for each of the 5 pre-specified cathegories.
Délai: 6-months

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:

  1. Basic assessment
  2. Stroke-heart syndrome
  3. Embolic stroke of undetermined source (ESUS) workup
  4. Patent foramen ovale (PFO) in young patients
  5. Atrial fibrillation (AF) management

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
Long-term achievement of the primary outcome at 12 months.
Délai: 12-months

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Exploratory endpoint. Major adverse cardiovascular events (MACE) at 12 months
Délai: 12-months

Major adverse cardiovascular events (MACE) at 12 months are defined as the composite of the following events:

  • Recurrent ischemic stroke.
  • Acute coronary event.
  • Admission or Emergency Department visit for decompensated heart failure (HF), AF, or valvular heart disease.
  • New diagnosis of coronary artery disease.
  • Cardiovascular death.
12-months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Luciano A. Sposato

Collaborateurs

W.L.Gore & Associates
Medtronic

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 mars 2027

Achèvement primaire (Estimé)

1 mars 2028

Achèvement de l'étude (Estimé)

1 décembre 2029

Dates d'inscription aux études

Première soumission

18 septembre 2024

Première soumission répondant aux critères de contrôle qualité

18 septembre 2024

Première publication (Réel)

20 septembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 14852

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime IPD

Upon reasonable request and after the Approval of Western University Ethics Review Board

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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