Detecting Atrial Fibrillation in Patients After Stroke
Develop and Validate Machine-Learning Algorithm to Detect Atrial Fibrillation With Wearable Devices
This study is testing a new smartwatch tool to see if it can help find atrial fibrillation in people who have had a stroke, to reduce their risk of having another one.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05795842 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a machine-learning software for long-term monitoring and detection of atrial fibrillation (AF) using biometric data collected from consumer smart devices like smartwatches. It will enroll 500 subjects who have experienced an ischemic stroke of uncertain cause and are being followed at the Emory Stroke Center. Participants will undergo standard extended ECG monitoring alongside the use of a wearable wristband. The goal is to improve the diagnosis of AF, which is often asymptomatic but can significantly increase the risk of subsequent strokes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 and older who have had an ischemic stroke of uncertain cause and are receiving follow-up care at the Emory Stroke Clinic.
Not a fit: Patients younger than 55 or those without a need for extended cardiac monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and treatment of atrial fibrillation, reducing the risk of future strokes in patients.
How similar studies have performed: Other studies have shown promise in using consumer technology for health monitoring, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 55 years of age or older. * Post-discharge with diagnostic of index ischemic stroke with uncertain cause. * Subject must be treated at the Emory Stroke Clinic for follow-up treatment. * Subject must be prescribed a clinical extended cardiac monitoring. * Subject or their Legal Authorized Representative (LAR) must be willing and able to provide informed consent. * Subject, family proxy, or caregiver must understand English and the instructions to manage and recharge the study wrist device. Exclusion Criteria: * Subject is younger than 55 years of age at the time of consent. * No indication for clinical extended cardiac monitoring. * Subject, family proxy, or caregiver unable to understand English and unable to follow the instructions on how to manage and recharge the study wrist device. * Subject has a diagnosis of structural valve disease, endocarditis, aortic arch atheroma \>3 mm, hypercoagulability, on lifelong anticoagulation, or has an active neoplastic disease * Subject or LAR is not willing or able to provide informed consent.
Where this trial is running
Atlanta, Georgia
- Emory Clinic — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Xiao Hu, PhD — Emory University, School of Nursing
- Study coordinator: Xiao Hu, PhD
- Email: xhu40@emory.edu
- Phone: 404-712-8520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.