RecruitingNot Applicable

Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

Spain100 participantsStarted 2022-03-28

Plain-language summary

Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Increased probability of detecting AF

Timeframe: Assessed throughout 1 year trial period

Trial details

NCT IDNCT05565781

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials