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RecruitingNCT05044208EPAF-7Updated Mar 8, 2023

Echocardiographic Predictors of Atrial Fibrillation

An observational study in Atrial Fibrillation, Stroke, Ischemic and Embolic Stroke of Undetermined Source, sponsored by Karl Landsteiner University of Health Sciences. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Karl Landsteiner University of Health Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Jan 2021; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

Cardiac thromboembolism attributed to atrial fibrillation (AF), the most frequent cardiac arrhythmia, is responsible for up to one-third of ischemic strokes.

Several factors have been proposed to predict AF, as findings in 12-lead ECG (electrocardiogram) or Holter ECG, epidemiological or echocardiographic parameters.

The main purpose of this research project is to test the diagnostic accuracy of the atrial electromechanical conduction time, measured as septal total atrial conduction time "sPA-TDI", an echocardiographic parameter, and the LaHAsPa-Score, which is based on patient characteristics and echocardiographic measurements for the detection of AF in patients diagnosed with ESUS or TIA, utilizing a 7-day ambulatory ECG monitor and incidental detection of AF during a two-year follow-up period, including detection via implantable cardiac monitor or pacemaker, if applicable.

Other echocardiographic measurements including left atrial volume index (area-length method), atrial electromechanical delay, left atrial myocardial strain together with laboratory, 12-channel ECG, Holter ECG findings, and established risk scores will be compared to the main parameters of interest.

The investigators expect that the results will help with better risk stratification and targeted monitoring periods for atrial fibrillation in patients with ESUS or TIA.

02

Conditions studied

  • Atrial Fibrillation
  • Stroke, Ischemic
  • Embolic Stroke of Undetermined Source
  • TIA, Brain

Keywords

  • Echocardiography
  • Total Atrial Conduction Time
  • Left Atrial Strain
  • Left Atrial Volume
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Karl Landsteiner University of Health Sciences is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥ 18 years, written to participate in the study Clinical diagnosis of ischemic stroke or + brain imaging to rule out hemorrhagic stroke.

  1. Stroke: ESUS, defined as all of the following:

    • 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, \<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.
  2. TIA: Patients fulfilling all above criteria and diagnostic work-up, except the detection of ischemic lesions by CT or MRI is optional and clinical symptoms last \< 1 hours.

All patients must undergo , transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent).

Patent foramen ovale is not an exclusion criterion. Planned or existing implantation of an implantable cardiac monitor or cardiac pacemaker is not an exclusion criterion.

Exclusion criteria

Exclusion Criteria:

  • History of AF, AF on 12-lead , 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
  • \< 1 month
  • Patients under custody or mentally not being able to give written
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • No atrial fibrillation detected

    In this cohort, AF is not detected in 7-day ECG monitoring or 2-years follow-up period

    Diagnostic Test: ECG monitoring

  • Atrial fibrillation detected

    In this cohort, AF is detected in 7-day ECG monitoring or 2-years follow-up period

    Diagnostic Test: ECG monitoring

Interventions

  • Diagnostic testECG monitoring

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • University Hospital Tulln
    Tulln, 3430, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: immediately following publication, no end date

Access criteria: Proposals should be directed to erol.erdik@tulln.lknoe.at, data access will be granted via a third party website. Anyone who wishes to access the de-identified data for research purposes is eligible.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05044208
Lead sponsor
Karl Landsteiner University of Health Sciences
Collaborators
NÖ Landesgesundheitsagentur, legal entity of University Hospitals in Lower Austria, Department of Internal Medicine, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria, Department of Neurology, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria
Responsible party
Erol Erdik (Principle Investigator, MD, Karl Landsteiner University of Health Sciences) — Principal investigator
First posted
Sep 14, 2021
Start date
Jan 1, 2021
Primary completion
Nov 2024 (estimated)
Completion
Nov 2026 (estimated)
Last update
Mar 8, 2023

Study contacts

Erol Erdik, MD
Contact
erol.erdik@tulln.lknoe.at
+4322729004 ext. 27721
Susanne Holak, MD
Contact
susanne.holak@tulln.lknoe.at
+4322729004
Herbert Frank, Professor
study director · Head of Internal Medicine Department, University Hospital Tulln

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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