About this trial
This prospective study aims to identify the diagnostic accuracy of echocardiographic predictors of atrial fibrillation in patients with ESUS (embolic stroke of undetermined source) or TIA (transient ischemic attack).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stroke detected by CT (computertomography) or MRI (magnetic resonance imaging) that is not lacunar. (Lacunar is defined as a subcortical (this includes pons and midbrain) 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/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts.)
Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis).
No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator, if needed.
Disqualifiers
History of AF, AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to inclusion into the study
Technical problems or bad quality of the echocardiogram making it impossible to measure the main parameters for calculating the LaHAsPa-Score (sPA-TDI, LAVI)
Wearing time < 1 week (combined recording time < 168 hours) due to patient withdrawing from study, patch dissolving or technical defects
Life expectancy < 1 month
Trial population
Patients who are hospitalized with ischemic stroke or TIA at the department of neurology, meet the eligibility criteria and are willing to participate with informed consent
Trial design
Cohort
Prospective
Treatments tested in this trial
ECG monitoring
Diagnostic testAfter clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established
Treatment groups
Trial outcomes
Primary outcomes
Detection of former unrecognized atrial fibrillation
AF will be defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds
Secondary outcomes
Detection of atrial fibrillation after 7 days in the follow-up period
participants wearing the device for more than a week or diagnosed with AF after home monitoring period by local physicians or via ICM (implantable cardiac monitor) or pacemaker
Recurrent ischemic stroke
occurence of ischemic stroke during the follow-up period
Participants on oral anticoagulation
participants who have been prescribed oral anticoagulants by their treating physician (for any reason)
Cardiovascular (CV) death
AMI (acute myocardial infarction), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage and other CV causes
Sponsors and contacts
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Karl Landsteiner University of Health Sciences
Lead sponsor
NÖ Landesgesundheitsagentur, legal entity of University Hospitals in Lower Austria
Collaborator
Department of Internal Medicine, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria
Collaborator
Department of Neurology, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria
Collaborator