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WSO BEAT STROKE Initiative

ConditionsStrokePFO - Patent Foramen OvaleAtrial Fibrillation (AF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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 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.

  • No educational or implementation tool will be provided

    Other intervention

    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.

Treatment groups

2,400 Participants
are divided into 2 treatment groups
Group A: No interventionPlacebo comparator 1 intervention
Group B: Intervention armActive comparator 1 intervention

Trial outcomes

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).

Time frame
6-months

Secondary outcomes

1

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

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.

Time frame
6-months
2

Long-term achievement of the primary outcome at 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).

Time frame
12-months

Other outcomes

1

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

Time frame
12-months

Sponsors and contacts

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

Lead sponsor

W.L.Gore & Associates

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: