WSO BEAT STROKE Initiative

NCT ID: NCT06606054

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Stroke PFO - Patent Foramen Ovale Atrial Fibrillation (AF)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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No intervention

This group will not receive any of the educational and/or implementation Neurocardiology until the data collection is completed.

Group Type PLACEBO_COMPARATOR

No educational or implementation tool will be provided

Intervention Type OTHER

Participants will be followed for up to 12 months. No educational or interventional tool will be provided to sites in this arm until the follow-up period has ended.

Intervention arm

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.

Group Type ACTIVE_COMPARATOR

Educational and implementation Neurocardiology tool

Intervention Type OTHER

Sites in this arm will be provided with an educational and implementation Neurocardiology tool aiming to 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.

Interventions

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Educational and implementation Neurocardiology tool

Sites in this arm will be provided with an educational and implementation Neurocardiology tool aiming to 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.

Intervention Type OTHER

No educational or implementation tool will be provided

Participants will be followed for up to 12 months. No educational or interventional tool will be provided to sites in this arm until the follow-up period has ended.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with ischemic stroke or TIA of any etiology.

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Heart & Brain Lab, Western University

London, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Diana Ayan, Pharm MSc

Role: CONTACT

519-685-8500 ext. 35826

Facility Contacts

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Diana Ayan, Pharm MSc

Role: primary

519-685-8500 ext. 35826

Jennifer Moussa

Role: backup

519-685-8500 ext. 33110

Other Identifiers

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14852

Identifier Type: -

Identifier Source: org_study_id

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