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| Name | Class |
|---|---|
| NÖ Landesgesundheitsagentur, legal entity of University Hospitals in Lower Austria | UNKNOWN |
| Department of Internal Medicine, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria | UNKNOWN |
| Department of Neurology, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No atrial fibrillation detected | In this cohort, AF is not detected in 7-day ECG monitoring or 2-years follow-up period |
| |
| Atrial fibrillation detected | In this cohort, AF is detected in 7-day ECG monitoring or 2-years follow-up period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG monitoring | Diagnostic Test | After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established |
|
| 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) |
| 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 |
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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.
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.
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erol Erdik, MD | Contact | +4322729004 | 27721 | erol.erdik@tulln.lknoe.at |
| Susanne Holak, MD | Contact | +4322729004 | susanne.holak@tulln.lknoe.at |
| Name | Affiliation | Role |
|---|---|---|
| Herbert Frank, Professor | Head of Internal Medicine Department, University Hospital Tulln | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tulln | Recruiting | Tulln | 3430 | Austria |
Individual participant data that underlie the results reported in this article, after deidentification
immediately following publication, no end date
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.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| UNKNOWN |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002545 | Brain Ischemia |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |