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: Recruiting
• Conditions: Embolic Stroke of Undetermined Source
• Intervention / Treatment: Device: C3+ Holter Monitor

• Study Type: Observational
• Enrollment (Anticipated): 500

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

• Denmark
  • Herlev
    • Copenhagen, Herlev, Denmark, 2730
      • Recruiting
      • Department of Cardiology, Herlev & Gentofte Hospital
    • Copenhagen, Herlev, Denmark, 2730
      • Recruiting
      • Department of Neurology, Herlev & Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Anticipated): January 27, 2022
• Study Completion (Anticipated): March 27, 2022

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: stroke; embolism; secondary prevention; transthoracic echocardiography; strain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemic Stroke; Stroke; Embolic Stroke
• Other Study ID Numbers: H-20037212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No