Embolic Stroke of Undetermined Source, Continuous Electrocardiography and Transthoracic ECHOcardiography in Hospitalized Patients With Ischemic Stroke

Embolic Stroke of Undetermined Source Clinical Trial

— ESECHO  

Official title:

Value of Transthoracic Echocardiography and Long-term Holter Monitoring Following Embolic Stroke of Undetermined Source Detected by Magnetic Resonance Imaging: A Prospective Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808258
• Other study ID #: H-20037212
• Status: Recruiting
• Start date: November 27, 2020
• Est. completion date: March 27, 2022

Study information

• Verified date: March 2021
• Source: Herlev and Gentofte Hospital
• Contact: Morten Kjøbek Lamberts, MD, PhD
• Phone: +4522434186
• Email: morten.kjoebek.lamberts[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Transthoracic echocardiography (TTE) is recommended in patients with ischemic stroke when cardiac etiology is suspected to help plan secondary stroke management. However, discrepancy for specific clinical recommendation exists between cardiologists and neurologists, and data evaluating usefulness of TTE in unselected patients with cryptogenic strokes (CS) and embolic strokes of undetermined source (ESUS) are lacking. The investigators sought to evaluate the value of routinely performed echocardiography in consecutive CS/ESUS patients. The investigators will perform TTE as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management. In addition, the researchers aim to evaluate the effectiveness of long-term continuous electrocardiogram (cECG) monitorering with newer Holter monitors to detect cardiac arrhythmia in patients with CS/ESUS.

In this prospective study, the investigators aim to evaluate 500 consecutive patients, regardless of age, in sinus rhythm with acute IS and potential cardioembolic stroke (CES) or cryptogenic stroke (CS/ESUS) according to Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. Strokes are determined by magnetic resonance imaging. The researchers will perform TTE as recommended by guidelines including agitated saline contrast and speckle-tracking to investigate potential implications for secondary stroke management.

The investigators aim to explore underlying heart conditions and comorbidities among CES and ESUS patients. Data will include left atrium morphology, atrial septal aneurysm, valvular disease, mural thrombus and patent foramen ovale (PFO). Focus will be analysis of data on older patients, as some studies indicate that in ESUS patients >60 years of age, there is a higher prevalence of PFO in patients with low atherosclerosis and cardioembolic risk.

This project can potentially guide cardiologists and neurologists, on common grounds, for stroke management of potential cardioembolic origin. Implications of referring all-comers with stroke of potential cardioembolic origin to echocardiography will be illustrated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients with verified acute ischemic stroke determined by magnetic resonance imaging (MRI) and/or computed tomography (CT) of cerebrum.

• Patients, regardless of age, in sinus rhythm with acute IS and potential cardioembolic stroke or cryptogenic stroke (CS/ESUS) according to Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.

Exclusion Criteria:

• Persons not able to cooperate.

• Persons unable to understand and sign "informed concent."

Related Conditions & MeSH terms

• Embolic Stroke of Undetermined Source
• Stroke

Intervention

Device:
• C3+ Holter Monitor
Long-Term ECG monitoring (up to 7 days)

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Herlev & Gentofte Hospital	Copenhagen	Herlev
Denmark	Department of Neurology, Herlev & Gentofte Hospital	Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number (percentage) of patients with underlying heart conditions	Use of echocardiographic metrics (especially left atrial metrics) to guide secondary stroke management of patients suffering from embolic stroke of undetermined source (ESUS)..	1 year
Primary	Agreement in electrocardiogram findings between device A (new Holter monitor) and device B (traditional Holter monitor)	Use of long-term continuous electrocardiogram (cECG) monitoring with newer Holter monitors to detect cardiac arrhythmia and guide secondary stroke management of patients suffering from embolic stroke of undetermined source (ESUS)	1 year