Impaired Endothelial Integrity in Patients With Embolic Stroke of Undetermined Source (ESUS)

NCT03609437 | Active Not Recruiting DMC

• 1 other identifier: esus-endothelium-attikon
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will measure endothelial glycocalyx, aortic elastic properties, oxidative stress, and their association with left ventricular (LV) and left atrial (LA) function in ESUS, cardioembolic, atherosclerotic, lacunar strokes and age- and sex-adjusted healthy individuals.

Conditions

Embolic Stroke of Undetermined Source; Endothelial Dysfunction

Keywords

Embolic stroke; Arterial stiffness; Endothelial function; Endothelial glycocalyx; Left ventricular function; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Comparison of endothelial glycocalyx thickness between patients with embolic stroke of undetermined source (ESUS), cardioembolic, atherosclerotic, lacunar strokes and controls

  Investigators will assess endothelial glycocalyx thickness by evaluating perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels (range 5-25 micrometers) for patients with embolic stroke of undetermined source (ESUS), cardioembolic, atherosclerotic, lacunar strokes and controls.

  Baseline

Secondary Outcomes (4)

• Comparison of arterial stiffness between patients with embolic stroke of undetermined source (ESUS), cardioembolic, atherosclerotic, lacunar strokes and controls.

  Baseline

• Assessment of left ventricular performance in patients with embolic stroke of undetermined source (ESUS), cardioembolic, atherosclerotic, lacunar strokes and controls.

  Baseline

• Serum malondialdehyde levels in patients with embolic stroke of undetermined source (ESUS), cardioembolic, atherosclerotic, lacunar strokes and controls.

  Baseline

• Assessment of left atrial performance in patients with embolic stroke of undetermined source (ESUS), cardioembolic, atherosclerotic, lacunar strokes and controls.

  Baseline

Study Arms (5)

ESUS patients

Acute ischemic stroke patients satisfying embolic stroke of undetermined source (ESUS) diagnostic criteria.

Controls

Healthy volunteers (colleagues, friends, relatives and others).

Lacunar stroke patients

Acute ischemic stroke patients satisfying lacunar stroke diagnostic criteria

Cardioembolic stroke patients

Acute ischemic stroke patients satisfying cardioembolic stroke diagnostic criteria

Atherosclerotic stroke patients

Acute ischemic stroke patients satisfying atherosclerotic stroke diagnostic criteria

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 172 consecutive patients with Ischemic stroke of undetermined source (ESUS) that fulfill inclusion criteria and 43 healthy volunteers of similar age and sex (control group)

You may qualify if:

• The investigators plan to include participants with Acute Ischemic Stroke, based on the TOAST classification : 1) large artery atherosclerosis (atherothrombotic), 2) cardioembolic, 3) small artery occlusion (lacunar), 4) stroke of undetermined etiology (ESUS). According to the TOAST classification, diagnoses are based on clinical presentation and on data collected by exams such as brain imaging (CT/MRI), cardiac imaging (echocardiography) and laboratory tests for the prothrombotic state. The diagnosis of Embolic Stroke of Undetermined Source (ESUS) was established based on the criteria defined by the Cryptogenic Stroke/ESUS International Working Group.

You may not qualify if:

• presence of acute haemorrhagic stroke,
• the presence of stroke of other determined etiology,
• the history of previous Ischemic stroke and/or Myocardial Infarction (MI),
• hypercoagulable state,
• active malignancy

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Konstantinos Katogiannis

Athens, Attica, 12461, Greece

Location

Related Publications (1)

• Ikonomidis I, Frogoudaki A, Vrettou AR, Andreou I, Palaiodimou L, Katogiannis K, Liantinioti C, Vlastos D, Zervas P, Varoudi M, Lambadiari V, Triantafyllidi H, Pavlidis G, Efentakis P, Tsoumani M, Tsantes AE, Parissis J, Revela I, Andreadou I, Tsivgoulis G. Impaired Arterial Elastic Properties and Endothelial Glycocalyx in Patients with Embolic Stroke of Undetermined Source. Thromb Haemost. 2019 Nov;119(11):1860-1868. doi: 10.1055/s-0039-1694752. Epub 2019 Aug 17.

  PMID: 31421641 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Embolic Stroke

Condition Hierarchy (Ancestors)

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ignatios Ikonomidis

  University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ignatios Ikonomidis,MD,PhD,FESC Associate Professor

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: August 1, 2018
• Study Start: January 1, 2018
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

GR (1)