Atrial FibrillationEPAF-7NCT05044208
Echocardiographic Predictors of Atrial Fibrillation
An observational study of Atrial Fibrillation and Stroke, Ischemic, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke, Ischemic, Embolic Stroke of Undetermined Source
- What is being tested?
- ECG monitoring
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2021to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age ≥ 18 years, written informed consent to participate in the study Clinical diagnosis of ischemic stroke or transient ischemic attack + brain imaging to rule out hemorrhagic stroke.
- 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, 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.
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- 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 electrocardiogram, 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.
Who cannot join
- 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
- Patients under custody or mentally not being able to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University Hospital Tulln
Tulln, 3430
Erol Erdik, MD, +4322729004 ext. 27721, erol.erdik@tulln.lknoe.at
Erol Erdik, MD
About this study
Official title: Echocardiographic Predictors of Atrial Fibrillation in Patients With ESUS or TIA - Detected With 7-day ECG Monitor
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.
- Being tested
- ECG monitoring
- Keywords
- Echocardiography, Total Atrial Conduction Time, Left Atrial Strain, Left Atrial Volume
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoringDiagnostic test
After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established
| Study group | Role | What they receive |
|---|---|---|
| No atrial fibrillation detected | In this cohort, AF is not detected in 7-day ECG monitoring or 2-years follow-up period Receives: Diagnostic Test: ECG monitoring | |
| Atrial fibrillation detected | In this cohort, AF is detected in 7-day ECG monitoring or 2-years follow-up period Receives: Diagnostic Test: ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days (168 hours of ECG recording)
Secondary outcomes (4)
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
Measured: 24 months
Recurrent ischemic stroke
occurence of ischemic stroke during the follow-up period
Measured: 24 months
Participants on oral anticoagulation
participants who have been prescribed oral anticoagulants by their treating physician (for any reason)
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Jan 2021
- Primary completionNov 2024 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Erol Erdik, Karl Landsteiner University of Health Sciences
- Investigators
- Herbert Frank, Professor, Study director, Head of Internal Medicine Department, University Hospital Tulln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044208
- Sponsor's protocol ID
- 1018/2020
- Acronym
- EPAF-7
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Predictors of Atrial Fibrillation in Patients With ESUS or TIA - Detected With 7-day ECG Monitor
- ClinicalTrials.gov ID
- NCT05044208
- Acronym / sponsor ID
- EPAF-7 / 1018/2020
- Keywords
- Echocardiography, Total Atrial Conduction Time, Left Atrial Strain, Left Atrial Volume
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- 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
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No atrial fibrillation detected | – | Diagnostic Test: ECG monitoringIn this cohort, AF is not detected in 7-day ECG monitoring or 2-years follow-up period |
| Atrial fibrillation detected | – | Diagnostic Test: ECG monitoringIn this cohort, AF is detected in 7-day ECG monitoring or 2-years follow-up period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- Age ≥ 18 years, written informed consent to participate in the study Clinical diagnosis of ischemic stroke or transient ischemic attack + brain imaging to rule out hemorrhagic stroke.
- Stroke: ESUS, defined as all of the following:
- 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 electrocardiogram, 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.
Key exclusion criteria (5 listed)
- 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
- Patients under custody or mentally not being able to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG monitoringAfter clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established | Diagnostic test | Atrial fibrillation detected, No atrial fibrillation detected |
Primary outcome
Detection of former unrecognized atrial fibrillation
Time frame: 7 days (168 hours of ECG recording)
AF will be defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds
4 secondary outcomes
Detection of atrial fibrillation after 7 days in the follow-up period
Time frame: 24 months
Recurrent ischemic stroke
Time frame: 24 months
Participants on oral anticoagulation
Time frame: 24 months
Cardiovascular (CV) death
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Herbert Frank, Professor study director
Head of Internal Medicine Department, University Hospital Tulln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, Ischemic, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erol Erdik, MD (+4322729004 ext. 27721, erol.erdik@tulln.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of former unrecognized atrial fibrillation (time frame: 7 days (168 hours of ECG recording)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.