Image

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

Recruiting
55 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Description

The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.

Eligibility

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

Study details

Paroxysmal Atrial Fibrillation, Cryptogenic Stroke

NCT05565781

Hospital Universitari Vall d'Hebron Research Institute

18 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.