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Status unknownNCT04808258ESECHOUpdated Mar 22, 2021

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

An observational study in Embolic Stroke of Undetermined Source, sponsored by Herlev and Gentofte Hospital. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Herlev and Gentofte Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Embolic Stroke of Undetermined Source

Keywords

  • transthoracic echocardiography
  • stroke
  • strain
  • embolism
  • secondary prevention
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 500 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All hospitalized patients with acute ischemic stroke from department of neurology (stroke unit) in University of Copenhagen Herlev Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Persons not able to cooperate.
  • Persons unable to understand and sign "informed concent."
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • DeviceC3+ Holter Monitor

    Long-Term ECG monitoring (up to 7 days)

06

What researchers measure

Primary outcomes

  1. 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)..

    Time frame: 1 year

  2. 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)

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
  • Department of Cardiology, Herlev & Gentofte Hospital
    Copenhagen, Herlev 2730, Denmark
    Recruiting
  • Department of Neurology, Herlev & Gentofte Hospital
    Copenhagen, Herlev 2730, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04808258
Lead sponsor
Herlev and Gentofte Hospital
Responsible party
Morten Lamberts (Associate Professor and Research Director, Herlev and Gentofte Hospital) — Principal investigator
First posted
Mar 22, 2021
Start date
Nov 27, 2020
Primary completion
Jan 27, 2022 (estimated)
Completion
Mar 27, 2022 (estimated)
Last update
Mar 22, 2021

Study contacts

Morten Kjøbek Lamberts, MD, PhD
Contact
morten.kjoebek.lamberts@regionh.dk
+4522434186
Mohammed El-Sheikh, B.Sc. Med.
Contact
mohammed.el-sheikh@regionh.dk
+4538681169

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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