Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT05565781

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

Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-04-04

100

Participants Needed

1

Research Sites

231 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater to or equal to 55 years
  • Diagnosis of cryptogenic stroke after neuroimaging, vascular evaluation, 24-hour monitoring, and echocardiogram
  • Acute cortical infarction preferably with intracranial occlusion
  • Modified Rankin Scale (mRS) less than 4
Not Eligible

You will not qualify if you...

  • Diagnosis of lacunar infarction or transient ischemic attack (TIA)
  • Stroke of known cause such as atherothrombotic stenosis, major cardioembolic cause, or unusual causes like thrombophilia or arterial dissection
  • Use of pacemakers
  • Conditions preventing clinical follow-up or data collection, such as transfer to a social health center
  • Unwillingness to use cardiac monitoring wearable devices
  • Inability to understand study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

3

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