WSO BEAT STROKE Initiative (BEAT STROKE)

March 27, 2025 updated by: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with ischemic stroke or TIA of any etiology.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No intervention
This group will not receive any of the educational and/or implementation Neurocardiology until the data collection is completed.
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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the baseline and 6-month mean WSO BEAT Neurocardiology Score
Time Frame: 6-months
Difference between the baseline and 6-month mean WSO BEAT Neurocardiology Score. The score for each patient will be calculated by adding the total points and dividing this number by the total ideal points for that patient, given that not all patients will qualify for the (embolic stroke of undetermined source (ESUS), PFO or AF points).
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the baseline and 6-month mean WSO BEAT Neurocardiology Score for each of the 5 pre-specified cathegories.
Time Frame: 6-months
Difference between the baseline and 6-month mean WSO BEAT Neurocardiology Score for each of the 5 pre-specified categories: basic assessment, stroke-heart syndrome, ESUS workup, PFO in young patients, and AF management.
6-months
Long-term achievement of the primary outcome at 12 months.
Time Frame: 12-months
Difference between the baseline and 12-month mean WSO BEAT Neurocardiology Score. The score for each patient will be calculated by adding the total points and dividing this number by the total ideal points for that patient, given that not all patients will qualify for the (embolic stroke of undetermined source (ESUS), PFO or AF points).
12-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory endpoint. Major adverse cardiovascular events (MACE) at 12 months
Time Frame: 12-months

Major adverse cardiovascular events (MACE) at 12 months 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

W.L.Gore & Associates
Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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