Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT06005233

Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke

Led by Technical University of Munich · Updated on 2024-12-13

400

Participants Needed

1

Research Sites

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Thus, prolonged ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a smartwatch could lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy and may constitute a cost-effective, non-invasive, and broadly-available alternative to the current standard of care. Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder. Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an implanted event recorder as indicated by clinical standard, included patients receive a smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set to evaluate start of anticoagulation. The follow-up period will be six months. The study consists of four study visits: a baseline visit, two phone visits at one and three months, and an end of trial visit at six months. Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity and specificity of AFib detection per patient after six months

CONDITIONS

Official Title

Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Implanted event recorder with telemedicine function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
  • Cryptogenic stroke within the last six months confirmed by CT or MRI, not lacunar
  • No extracranial or intracranial artery stenosis causing 50 percent or more narrowing in the ischemic area
  • No major-risk cardioembolic sources such as permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumors, high-grade mitral valve stenosis, recent myocardial infarction within four weeks, left ventricular ejection fraction below 30 percent, valvular vegetations, or infective endocarditis
  • No other specific causes of stroke like arteritis, dissection, migraine, vasospasm, or drug abuse
  • No paroxysmal atrial fibrillation detected in 72 hours of in-hospital ECG monitoring including at least one 24-hour Holter ECG
  • Cryptogenic transient ischemic attack with definite cortical syndrome within the last six months
  • Age 40 years or older
  • At least one risk factor: CHA2DS2VASc score 4 or higher, atrial runs, left atrial size over 45 mm, or left atrial appendage flow 0.2 m/s or less
  • No contraindication for anticoagulant therapy after the acute phase of stroke
  • Written informed consent by patient or authorized caregiver
Not Eligible

You will not qualify if you...

  • Unable to perform 1-lead ECG recording with smartwatch
  • No smartphone with iOS version 10.0 or Android operating system
  • Implanted pacemaker or cardioverter defibrillator (ICD)
  • Pregnancy or breastfeeding period

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Klinikum rechts der Isar, Technische Universität München

Munich, Germany, 81675

Actively Recruiting

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Research Team

S

Silke Wunderlich, Dr.med

CONTACT

H

Horst Penkert, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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