WSO BEAT STROKE Initiative

ConditionsStroke PFO - Patent Foramen Ovale Atrial Fibrillation (AF)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLuciano A. Sposato

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ischemic stroke or TIA of any etiology.

Disqualifiers

N/A

Trial design

Design model

Parallel

Treatments tested in this trial

Educational and implementation Neurocardiology tool
Other intervention
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 intervention
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.

Treatment groups

2,400 Participants

are divided into 2 treatment groups

Group A: No intervention arm - Standard of Care for the institutionPlacebo comparator 1 intervention

Group B: Intervention arm - Educational and implementation Neurocardiology toolActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

6-months

Secondary outcomes

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

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.

Time frame

6-months

Long-term achievement of the primary outcome at 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

Time frame

12-months

Other outcomes

Exploratory endpoint. Major adverse cardiovascular events (MACE) at 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.

Time frame

12-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luciano A. Sposato

Lead sponsor

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

Sponsor institution

W.L.Gore & Associates

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov

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