Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT06606054

WSO BEAT STROKE Initiative

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Nervous System Diseases PFO - Patent Foramen Ovale Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ischemic stroke or TIA of any etiology.

Exclusion criteria

  • N/A

Treatment and study plan

Educational and implementation Neurocardiology tool

Other

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.

No educational or implementation tool will be provided

Other

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.

Primary outcomes

  1. Difference between the baseline and 6-month mean WSO BEAT-STROKE Neurocardiology Score

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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:

    • Basic assessment
    • Stroke-heart syndrome
    • Embolic stroke of undetermined source (ESUS) workup
    • Patent foramen ovale (PFO) in young patients
    • 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.

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

    Time frame: 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

Other outcomes

  1. Exploratory endpoint. Major adverse cardiovascular events (MACE) at 12 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Ayan, Pharm MSc

CONTACT

[email protected]

519-685-8500 ext. 35826

Sponsors and collaborators

Lead sponsor

Luciano A. Sposato

Other

Collaborators

  • Medtronic
  • W.L.Gore & Associates

Registry information

Official study title

WSO - The Brain and hEart globAl iniTiative (BEAT) Stroke

Acronym: BEAT STROKE

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Sep 20, 2024
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.