Identifying echocardiographic predictors of atrial fibrillation
Echocardiographic Predictors of Atrial Fibrillation in Patients With ESUS or TIA - Detected With 7-day ECG Monitor
This study is testing if certain heart ultrasound measurements can help find atrial fibrillation in patients who have had a stroke or a mini-stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karl Landsteiner University of Health Sciences Academic / other |
| Locations | 1 site (Tulln) |
| Trial ID | NCT05044208 on ClinicalTrials.gov |
What this trial studies
This prospective observational study aims to evaluate the diagnostic accuracy of echocardiographic predictors for atrial fibrillation (AF) in patients who have experienced an embolic stroke of undetermined source (ESUS) or a transient ischemic attack (TIA). The study will utilize various echocardiographic measurements, including total atrial conduction time and left atrial strain, alongside a 7-day ambulatory ECG monitor to detect AF over a two-year follow-up period. By comparing these parameters with established risk scores and other diagnostic tools, the research seeks to improve risk stratification and monitoring for AF in affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been clinically diagnosed with ischemic stroke or TIA and have undergone brain imaging to exclude hemorrhagic stroke.
Not a fit: Patients with a confirmed diagnosis of atrial fibrillation or those with significant atherosclerosis causing stenosis in the arteries supplying the area of ischemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of atrial fibrillation, potentially reducing the risk of subsequent strokes in patients.
How similar studies have performed: Other studies have shown promise in using echocardiographic parameters to predict atrial fibrillation, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tulln
- University Hospital Tulln — Tulln, Austria (Recruiting)
Study contacts
- Study coordinator: Erol Erdik, MD
- Email: erol.erdik@tulln.lknoe.at
- Phone: +4322729004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.