Actively Recruiting
Echocardiographic Predictors of Atrial Fibrillation in Patients With ESUS or TIA Using 7-day ECG Monitoring
Led by Karl Landsteiner University of Health Sciences · Updated on 2023-03-08
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
K
Karl Landsteiner University of Health Sciences
Lead Sponsor
N
NÖ Landesgesundheitsagentur, legal entity of University Hospitals in Lower Austria
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the accuracy of echocardiographic measurements to predict atrial fibrillation (AF) in patients who have experienced embolic stroke of undetermined source (ESUS) or transient ischemic attack (TIA). The study focuses on testing the atrial electromechanical conduction time, measured as septal total atrial conduction time (sPA-TDI), and the LaHAsPa-Score, which combines patient data and echocardiographic findings. The goal is to improve risk assessment and monitoring for AF in these patients. Participants undergo a 7-day ambulatory ECG monitoring after routine clinical diagnostics to detect AF. The study follows patients for up to two years to identify AF occurrences, including detection through implantable cardiac monitors or pacemakers if applicable. Other echocardiographic measures and diagnostic tests like 12-lead ECG and Holter monitoring are also compared to the main parameters. During the study, participants receive brain imaging to confirm stroke or TIA diagnosis and echocardiography to measure heart function. They are monitored using ECG devices over extended periods, with regular follow-up visits assessing stroke recurrence, anticoagulation therapy, and cardiovascular events. The primary outcome is detection of previously unrecognized AF during the initial 7-day ECG recording, with secondary outcomes monitored over two years.
CONDITIONS
Brief Title
Echocardiographic Predictors of Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent to participate
- Clinical diagnosis of ischemic stroke or transient ischemic attack (TIA) with brain imaging to exclude hemorrhagic stroke
- Diagnosis of embolic stroke of undetermined source (ESUS) defined by specific imaging and absence of significant artery narrowing or major cardioembolic sources
- Patients with TIA meeting the above criteria except ischemic lesions on imaging are optional and symptoms last less than 1 hour
- Completion of electrocardiogram, transthoracic or transesophageal echocardiography, and at least 24 hours of heart rhythm monitoring
- Patent foramen ovale allowed
- Planned or existing implantable cardiac monitor or pacemaker device allowed
You will not qualify if you...
- History of atrial fibrillation or atrial fibrillation detected on any prior ECG or heart rhythm monitoring
- Poor quality echocardiogram preventing measurement of key parameters for the LaHAsPa-Score
- Wearing time of ECG monitor less than 7 days due to withdrawal, technical issues, or patch problems
- Life expectancy less than 1 month
- Patients under legal custody or unable to give written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants undergo additional ambulatory ECG monitoring for 7 days to detect atrial fibrillation following routine clinical diagnostics.
1 visit to start monitoring and continuous ECG monitoring for 7 days
Duration - 24 months
Participants are followed for up to 24 months to monitor for detection of atrial fibrillation or recurrent ischemic stroke using implantable devices or pacemakers if applicable.
Periodic assessments during follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
University Hospital Tulln
Tulln, Austria, 3430
Actively Recruiting
Research Team
E
Erol Erdik, MD
S
Susanne Holak, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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