Educational Tool for Stroke Prevention

(BEAT STROKE Trial)

Overseen By Diana Ayan, Pharm MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an educational tool can help individuals adhere to best practices for preventing another stroke after a cardioembolic stroke. A cardioembolic stroke occurs when a clot in the heart travels to the brain. Participants will either use the new Neurocardiology Tool (an educational tool) or not, to determine its effectiveness. Individuals who have experienced an ischemic stroke (caused by a blocked blood vessel) or a TIA (a mini-stroke) may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on educational tools for stroke prevention, so it's best to ask the trial coordinators for more details.

What prior data suggests that this Neurocardiology tool is safe for stroke prevention?

Research has shown that educational tools like the Neurocardiology Tool can help people understand and follow strategies to prevent strokes. This tool is safe, focusing on teaching rather than medication or surgery.

The main aim is to guide patients in following best practices to prevent strokes related to heart problems. These tools have helped people learn about their health without causing harm. Since this study focuses on education, it avoids the risks associated with new drugs or surgeries.

In summary, the Neurocardiology Tool is safe because it emphasizes learning and improving health habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neurocardiology tool because it offers a fresh approach to stroke prevention by focusing on education and implementation. Unlike traditional treatments that primarily involve medications like anticoagulants and antiplatelets, this tool aims to improve adherence to best practice recommendations for preventing secondary cardioembolic strokes through educational strategies. By potentially increasing patient and provider adherence to existing global stroke guidelines, it could enhance the effectiveness of current preventive measures and reduce the risk of recurrent strokes.

What evidence suggests that the Neurocardiology Tool is effective for stroke prevention?

Research has shown that educational tools can help patients understand and follow stroke prevention methods more effectively. This trial tests the Neurocardiology Tool as an educational and implementation resource to teach patients how to prevent another stroke, particularly those linked to heart problems. Participants in the intervention arm will receive the Neurocardiology Tool, which aims to improve adherence to best practice recommendations for secondary stroke prevention. Studies have found that following best practice guidelines can significantly lower the chance of having another stroke. For example, taking certain medications can reduce the risk by up to 68%. By focusing on education and implementing these practices, the Neurocardiology Tool aims to help patients prevent future strokes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

The WSO BEAT STROKE trial is for individuals who have had a stroke, specifically those with conditions like Patent Foramen Ovale or Atrial Fibrillation. It aims to see if following certain guidelines can prevent another stroke.

Inclusion Criteria

I have had a stroke or a transient ischemic attack.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Sites receive the educational and implementation Neurocardiology tool to improve adherence to best practice recommendations for secondary stroke prevention

6 months

Follow-up

Participants are monitored for major adverse cardiovascular events and Neurocardiology Score improvements

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Neurocardiology Tool

Trial Overview This study tests an educational tool designed to help doctors stick to the best practices for preventing strokes that come from heart-related issues. Some participants will use this tool, while others won't, to compare outcomes.

How Is the Trial Designed?

Group I: Intervention arm Active Control 1 Intervention

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.

Group II: No intervention Placebo Group 1 Intervention

This group will not receive any of the educational and/or implementation Neurocardiology until the data collection is completed.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

W.L.Gore & Associates

Industry Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

In a study of 468 stroke patients, severe adverse events were found to be significantly more common in those who died compared to those who were discharged, with 76.5% of events occurring in deceased patients.

Major adverse events, particularly those related to medical procedures and nursing activities, were strongly associated with death, highlighting the need for improved safety measures in stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and death in stroke patients admitted to the emergency department of a tertiary university hospital. Daud-Gallotti, R., Dutilh Novaes, HM., Lorenzi, MC., et al.[2019]

An educational program for hypertensive patients after a stroke significantly improved their knowledge about their condition, with correct response rates increasing from 77.9% to 94.1% after the intervention.

The program also led to better medication adherence and more frequent self-measurement of blood pressure, indicating that education can play a crucial role in managing health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. Ben Nasr, N., Rouault, A., Cornillet, N., et al.[2021]

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

The study developed the IschAEmic Stroke Calculator, an online tool that predicts the incidence of adverse events (AEs) in acute stroke trials based on patient characteristics, using data from the Virtual International Stroke Trials Archive (VISTA).

This calculator identifies 48 common AEs and allows researchers to compare predicted incidences with observed data, aiding in the interpretation of trial safety and potentially guiding preventive measures in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Tool to Improve Stratification of Adverse Events in Stroke Clinical Trials. Hesse, K., MacIsaac, RL., Abdul-Rahim, AH., et al.[2021]

A collaborative calibration process among teams from 4 dental institutions led to an 82.2% agreement rate in identifying adverse events (AEs) in dental care, highlighting the importance of teamwork in improving patient safety.

The study found that categorizing the severity of AEs had a higher agreement rate (82.2%) compared to identifying the events themselves, suggesting that training and consensus-building are crucial for accurately assessing AEs in dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Consensus for a Shared Definition of Adverse Events: A Case Study in the Profession of Dentistry. Franklin, A., Kalenderian, E., Hebballi, N., et al.[2023]

A comprehensive multilingual patient education package, including SMS, videos, and workbooks, was developed to improve medication compliance and reduce stroke risk factors in patients with recent strokes, involving input from 355 stakeholders.

The educational materials were found to be highly understandable, with an average assessment score of over 95%, and no implementation issues were reported by patients or research coordinators after one month, indicating readiness for further testing in a randomized control trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Development of Structured Semi-interactive Stroke Prevention Package for Secondary Stroke Prevention. Kate, MP., Verma, SJ., Arora, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06606054

Study Details | NCT06606054 | WSO BEAT STROKE Initiative Sites randomized in this arm will receive the educational and implementation Neurocardiology tool with the aim of improving adherence to best practice ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10564024/

Evaluation and Prevention of Cardioembolic Stroke - PMC Warfarin can effectively reduce the risk of stroke by up to 68% (95% CI 50% to 79%), which corresponds to an absolute reduction in the annual risk of stroke ...

3. withpower.com withpower.com/trial/phase-stroke-9-2024-a5d78

Educational Tool for Stroke Prevention (BEAT STROKE Trial) The Neurocardiology Tool is unique because it focuses on using educational technologies to improve patient understanding and compliance with stroke prevention ...

4. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000375

2021 Guideline for the Prevention of Stroke in Patients With ... This guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke etiology (when possible), and ...

5. journals.lww.com journals.lww.com/brci/fulltext/2024/10040/recent_advances_in_the_prevention_of_secondary.1.aspx

Recent advances in the prevention of secondary ischemic... These trials suggested that early initiation of DAPT after a minor stroke or high-risk TIA was more effective than single antiplatelet therapy for secondary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3250282/

Prevention of Cardioembolic Stroke - PMC - PubMed Central The best way to prevent cardioembolic stroke remains early detection and treatment of AF, and treating the underlying stroke mechanism.

7. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1525966/full

Clinical applications of artificial intelligence and machine ... Our review shows an evident interest and exciting new frontier for neurocardiology with artificial intelligence and machine learning.

8. ahajournals.org ahajournals.org/doi/full/10.1161/STROKEAHA.121.035307?doi=10.1161/STROKEAHA.121.035307

Moving Towards Equity With Digital Health Innovations for ... The data shows that patients like Ms. S are much less likely to access mHealth tools that improve stroke prevention, when potentially, they stand to benefit ...