Echocardiographic Predictors of Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarl Landsteiner University of Health Sciences

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ECG monitoring

    Diagnostic test

    After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: No atrial fibrillation detected1 intervention
Group B: Atrial fibrillation detected1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
7 days (168 hours of ECG recording)

Secondary outcomes

1

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

Time frame
24 months
2

Recurrent ischemic stroke

occurence of ischemic stroke during the follow-up period

Time frame
24 months
3

Participants on oral anticoagulation

participants who have been prescribed oral anticoagulants by their treating physician (for any reason)

Time frame
24 months
4

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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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