- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808258
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Morten Kjøbek Lamberts, MD, PhD
- Phone Number: +4522434186
- Email: morten.kjoebek.lamberts@regionh.dk
Study Contact Backup
- Name: Mohammed El-Sheikh, B.Sc. Med.
- Phone Number: +4538681169
- Email: mohammed.el-sheikh@regionh.dk
Study Locations
-
-
Herlev
-
Copenhagen, Herlev, Denmark, 2730
- Recruiting
- Department of Cardiology, Herlev & Gentofte Hospital
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Copenhagen, Herlev, Denmark, 2730
- Recruiting
- Department of Neurology, Herlev & Gentofte Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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."
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number (percentage) of patients with underlying heart conditions
Time Frame: 1 year
|
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)
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20037212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Embolic Stroke of Undetermined Source
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University Hospital TuebingenBristol-Myers Squibb; Medtronic; ZKS and IKEaB TübingenCompletedEmbolic Stroke of Undetermined SourceGermany
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Fondation Ophtalmologique Adolphe de RothschildCompletedIschemic Stroke | Embolic Stroke of Undetermined SourceFrance
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Population Health Research InstituteCompletedEmbolic Stroke of Undetermined SourceAustralia, United Kingdom, Canada, France, United States, Germany, Spain, Argentina, Chile, Mexico, Poland, South Africa, Switzerland
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University of ThessalyUniversity of Athens; University of LausanneUnknown
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University of British ColumbiaBoehringer IngelheimCompletedEmbolic Stroke of Undetermined SourceCanada
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University of AthensCompletedEndothelial Dysfunction | Embolic Stroke of Undetermined SourceGreece
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Peking University Third HospitalCompletedEmbolic Stroke of Undetermined Source
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National Taiwan University HospitalUnknown
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HelpWear Inc.CompletedPreliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial (PRE-ALERT)Atrial Fibrillation | Tachycardia, Supraventricular | Ventricular Arrythmia | BradyarrhythmiaCanada
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