Using smartwatches and Holter monitors to find hidden atrial fibrillation in stroke patients
Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
This study is testing if using smartwatches and Holter monitors can help find hidden cases of atrial fibrillation in stroke patients aged 55 and older better than the usual 30-day monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT05565781 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if long-term monitoring with wearable devices, such as smartwatches and external Holter monitors, can detect more cases of occult atrial fibrillation (AF) in patients who have experienced a cryptogenic stroke compared to traditional 30-day monitoring. The study will involve patients aged 55 and older who have had a stroke, and will assess the effectiveness of smartwatches against insertable cardiac monitors. Additionally, it will evaluate patient adherence to using these devices and identify predictors of long-term AF and vascular events.
Who should consider this trial
Good fit: Ideal candidates are patients aged 55 and older who have experienced a cryptogenic stroke and meet specific diagnostic criteria.
Not a fit: Patients with known sources of stroke or those with certain cardiac devices, like pacemakers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of atrial fibrillation, potentially reducing the risk of recurrent strokes in patients.
How similar studies have performed: Previous studies have shown promise in using wearable technology for cardiac monitoring, but this specific long-term approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater to or equal to 55 years * Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram * Patients with acute cortical infarction with the presence of intracranial occlusion (preferably) * Modified Rankin Scale (mRS) lower to 4 Exclusion Criteria: * Diagnosis of lacunar infarction or transient ischemic attack (TIA) * Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic) * Use of pacemakers * Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center) * Unwillingness to the use of cardiac monitoring wearable devices * Not understanding study procedures
Where this trial is running
Barcelona, Catalonia
- Hospital Universitari Vall d'Hebron — Barcelona, Catalonia, Spain (Recruiting)
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.