Clinical trial NCT06606054: WSO BEAT STROKE Initiative
Official title: WSO - The Brain and hEart globAl iniTiative (BEAT) Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
PFO - Patent Foramen Ovale
Atrial Fibrillation (AF)
Keywords: cardiac monitoring
stroke
atrial fibrillation
pfo closure
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: W.L.Gore & Associates
name: Medtronic
First posted: 2024-09-20
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed description: The World Stroke Organization (WSO) Brain and Heart Task Force developed The Brain \&amp;amp; 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.

Eligibility criteria: Inclusion Criteria:

* Patients with ischemic stroke or TIA of any etiology.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Difference between the baseline and 6-month mean WSO BEAT Neurocardiology Score
timeFrame: 6-months
Secondary outcomes:
measure: Difference between the baseline and 6-month mean WSO BEAT Neurocardiology Score for each of the 5 pre-specified cathegories.
timeFrame: 6-months
measure: Long-term achievement of the primary outcome at 12 months.
timeFrame: 12-months
Other outcomes:
measure: Exploratory endpoint. Major adverse cardiovascular events (MACE) at 12 months
timeFrame: 12-months
Locations:
city: London
country: Canada
facility: Heart &amp; Brain Lab, Western University
state: Ontario
Study officials:
References: