Status:
RECRUITING
Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke
Lead Sponsor:
Technical University of Munich
Conditions:
Ischemic Stroke, Cryptogenic
Transient Ischemic Attack
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 6...
Detailed Description
Ischemic stroke is worldwide the second most frequent cause of death and disability and has a lifetime risk of approximately 25%. In the secondary prevention of ischemic stroke, detection of atrial fi...
Eligibility Criteria
Inclusion
- Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
- Cryptogenic stroke (within the last six month) after full standard evaluation:
- Stroke detected by computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (lacunar is defined as a subcortical infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images)
- Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia
- No major-risk cardioembolic source of embolism (i.e., no 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 (within four weeks) myocardial infarction, left ventricular ejection fraction \<30 percent, valvular vegetations, or infective endocarditis)
- No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, vasospasm, drug abuse)
- No paroxysmal atrial fibrillation in 72h of in-hospital ECG-monitoring, including at least one Holter- ECG for 24 hours.
- Cryptogenic TIA with definite cortical syndrome (aphasia, neglect or homonymous hemianopia) (within the last six month) after full standard evaluation (see above)
- Age: ≥40 yrs.
- At least one of the following risk factors:
- CHA2DS2VASc score ≥4
- Atrial runs
- Left atrial size \> 45mm
- Left atrial appendage flow ≤ 0.2m/s
- No contraindication for anticoagulant therapy after acute phase of stroke
- Written informed consent by patient or authorized caregiver
Exclusion
- Patient is not able to perform 1-lead ECG recording with smartwatch
- Patient possesses no smartphone (iOS version ≥10.0 or Android)
- Implanted pacemaker or cardioverter defibrillator (ICD)
- Pregnancy and breastfeeding period
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06005233
Start Date
October 15 2024
End Date
July 1 2026
Last Update
December 13 2024
Active Locations (1)
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1
Klinikum rechts der Isar, Technische Universität München
Munich, Germany, 81675