Embolic Stroke of Undetermined Source, Continuous Electrocardiography and Transthoracic ECHOcardiography in Hospitalized Patients With Ischemic Stroke
ESECHO
Value of Transthoracic Echocardiography and Long-term Holter Monitoring Following Embolic Stroke of Undetermined Source Detected by Magnetic Resonance Imaging: A Prospective Clinical Study
1 other identifier
observational
500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 27, 2020
CompletedFirst Submitted
Initial submission to the registry
February 21, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2022
CompletedMarch 22, 2021
March 1, 2021
1.2 years
February 21, 2021
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Interventions
Long-Term ECG monitoring (up to 7 days)
Eligibility Criteria
All hospitalized patients with acute ischemic stroke from department of neurology (stroke unit) in University of Copenhagen Herlev Hospital.
You may qualify if:
- 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.
You may not qualify if:
- Persons not able to cooperate.
- Persons unable to understand and sign "informed concent."
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Cardiology, Herlev & Gentofte Hospital
Copenhagen, Herlev, 2730, Denmark
Department of Neurology, Herlev & Gentofte Hospital
Copenhagen, Herlev, 2730, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor and Research Director
Study Record Dates
First Submitted
February 21, 2021
First Posted
March 22, 2021
Study Start
November 27, 2020
Primary Completion
January 27, 2022
Study Completion
March 27, 2022
Last Updated
March 22, 2021
Record last verified: 2021-03