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WSO BEAT STROKE Initiative (BEAT STROKE)

15. september 2026 opdateret af: Luciano A. Sposato

WSO - The Brain and HEart Global Initiative (BEAT) Stroke

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Heart & Brain Lab, Western University
        • Ledende efterforsker:
          • Luciano Sposato, MD, MBA
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with ischemic stroke or TIA of any etiology.

Exclusion Criteria:

  • N/A

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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.
Andet: 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.
Aktiv komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score for each of the 5 pre-specified cathegories.
Tidsramme: 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.
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory endpoint. Major adverse cardiovascular events (MACE) at 12 months
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Luciano A. Sposato

Samarbejdspartnere

W.L.Gore & Associates
Medtronic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

18. september 2024

Først indsendt, der opfyldte QC-kriterier

18. september 2024

Først opslået (Faktiske)

20. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14852

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

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

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