WSO BEAT STROKE Initiative

NCT06606054 | Not Yet Recruiting

• 1 other identifier: 14852
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; PFO - Patent Foramen Ovale; Atrial Fibrillation (AF)

Keywords

cardiac monitoring; stroke; atrial fibrillation; pfo closure

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

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

  6-months

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

  12-months

Other Outcomes (1)

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

  12-months

Study Arms (2)

No intervention

PLACEBO COMPARATOR

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

Intervention arm

ACTIVE COMPARATOR

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

Interventions

Educational and implementation Neurocardiology tool 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.

Intervention arm

No educational or implementation tool will be provided 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.

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ischemic stroke or TIA of any etiology.

You may not qualify if:

• N/A

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• W.L.Gore & Associates: collaborator
• Medtronic: collaborator

Study Sites (1)

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Diana Ayan, Pharm MSc

CONTACT

519-685-8500; diana.ayan@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CA (1)