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

NCT ID: NCT04808258

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-27

Study Completion Date

2022-03-27

Brief Summary

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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.

Detailed Description

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Conditions

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Embolic Stroke of Undetermined Source

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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C3+ Holter Monitor

Long-Term ECG monitoring (up to 7 days)

Intervention Type DEVICE

Eligibility Criteria

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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."
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Lamberts

Associate Professor and Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology, Herlev & Gentofte Hospital

Copenhagen, Herlev, Denmark

Site Status RECRUITING

Department of Neurology, Herlev & Gentofte Hospital

Copenhagen, Herlev, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Kjøbek Lamberts, MD, PhD

Role: CONTACT

+4522434186

Mohammed El-Sheikh, B.Sc. Med.

Role: CONTACT

+4538681169

Other Identifiers

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H-20037212

Identifier Type: -

Identifier Source: org_study_id

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