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| Name | Class |
|---|---|
| W.L.Gore & Associates | INDUSTRY |
| Medtronic | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | Placebo Comparator | This group will not receive any of the educational and/or implementation Neurocardiology until the data collection is completed. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Ayan, Pharm MSc | Contact | 519-685-8500 | 35826 | diana.ayan@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart & Brain Lab, Western University | London | Ontario | N6A 5A5 | Canada |
Upon reasonable request and after the Approval of Western University Ethics Review Board
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D054092 | Foramen Ovale, Patent |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
| 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). | 12-months |
| 12-months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |