Echocardiographic Predictors of Atrial Fibrillation

NCT05044208 | Recruiting

• 1 other identifier: 1018/2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation; Stroke, Ischemic; Embolic Stroke of Undetermined Source; TIA, Brain

Keywords

Echocardiography; Total Atrial Conduction Time; Left Atrial Strain; Left Atrial Volume

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Detection of atrial fibrillation after 7 days in the follow-up period

  24 months

• Recurrent ischemic stroke

  24 months

• Participants on oral anticoagulation

  24 months

• Cardiovascular (CV) death

  24 months

Study Arms (2)

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

Atrial fibrillation detected

In this cohort, AF is detected in 7-day ECG monitoring or 2-years follow-up period

Diagnostic Test: ECG monitoring

Interventions

ECG monitoring DIAGNOSTIC_TEST

After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established

Atrial fibrillation detected; No atrial fibrillation detected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• NÖ Landesgesundheitsagentur, legal entity of University Hospitals in Lower Austria: collaborator
• Department of Internal Medicine, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria: collaborator
• Department of Neurology, University Hospital Tulln, Alter Ziegelweg 10, 3430, Tulln, Austria: collaborator

Study Sites (1)

University Hospital Tulln

Tulln, 3430, Austria

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke; Ischemic Attack, Transient

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Herbert Frank, Professor

  Head of Internal Medicine Department, University Hospital Tulln

  STUDY DIRECTOR

Central Study Contacts

Erol Erdik, MD

CONTACT

+4322729004; erol.erdik@tulln.lknoe.at

Susanne Holak, MD

CONTACT

+4322729004; susanne.holak@tulln.lknoe.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, MD

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: January 1, 2021
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: immediately following publication, no end date
• 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.

Locations

AU (1)