Echocardiographic Predictors of Atrial Fibrillation (EPAF-7)

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).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Stroke, Ischemic; Embolic Stroke of Undetermined Source; TIA, Brain
• Intervention / Treatment: Diagnostic test: ECG monitoring

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Erol Erdik, MD; Phone Number: 27721 +4322729004; Email: erol.erdik@tulln.lknoe.at
• Study Contact Backup: Name: Susanne Holak, MD; Phone Number: +4322729004; Email: susanne.holak@tulln.lknoe.at

Study Locations

• Austria
  • Tulln, Austria, 3430
    • Recruiting
    • University Hospital Tulln
    • Contact: Erol Erdik, MD; Phone Number: 27721 +4322729004; Email: erol.erdik@tulln.lknoe.at
    • Principal Investigator: Erol Erdik, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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.

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, 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.
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 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established
Atrial fibrillation detected; In this cohort, AF is detected in 7-day ECG monitoring or 2-years follow-up period	Diagnostic test: ECG monitoring; After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days (168 hours of ECG recording)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months
Recurrent ischemic stroke	occurence of ischemic stroke during the follow-up period	24 months
Participants on oral anticoagulation	participants who have been prescribed oral anticoagulants by their treating physician (for any reason)	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	24 months

Collaborators and Investigators

• 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
• Investigators: Study Director: Herbert Frank, Professor, Head of Internal Medicine Department, University Hospital Tulln

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Echocardiography; Total Atrial Conduction Time; Left Atrial Strain; Left Atrial Volume
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Brain Ischemia; Stroke; Ischemic Stroke; Ischemic Attack, Transient; Atrial Fibrillation; Embolic Stroke
• Other Study ID Numbers: 1018/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification
• IPD Sharing Time Frame: immediately following publication, no end date
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No