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

NCT ID: NCT03609437

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2026-06-30

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.

Detailed Description

Investigators plan to include male and female patients, aged 18 to 75 years old admitted and hospitalized in the 2nd Neurology Department of Attikon University Hospital for Acute Ischemic Stroke, based on the Trial of Org 10172 in Acute Stroke Treatment TOAST classification. The TOAST classification consists of five categories: 1) large artery atherosclerosis (atherothrombotic), 2) cardioembolic, 3) small artery occlusion (lacunar), 4) stroke of undetermined etiology (ESUS).

In participants (patients and controls) the investigators plan to measure and compare: a) perfused boundary region (PBR) of the sublingual arterial microvessels (range 5-25 micrometers), a marker inversely related with glycocalyx thickness, b) pulse wave velocity (PWV), central systolic blood pressure (cSBP) and augmentation index (AIx), c) LV Global Longitudinal strain (GLS), d) LA volume and strain using speckle-tracking strain imaging, e) Malondialdehyde (MDA), as an oxidative stress marker.

Conditions

Embolic Stroke of Undetermined Source; Endothelial Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

ESUS patients

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

No interventions assigned to this group

Controls

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

No interventions assigned to this group

Lacunar stroke patients

Acute ischemic stroke patients satisfying lacunar stroke diagnostic criteria

No interventions assigned to this group

Cardioembolic stroke patients

Acute ischemic stroke patients satisfying cardioembolic stroke diagnostic criteria

No interventions assigned to this group

Atherosclerotic stroke patients

Acute ischemic stroke patients satisfying atherosclerotic stroke diagnostic criteria

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

1. presence of acute haemorrhagic stroke,

2. the presence of stroke of other determined etiology,

3. the history of previous Ischemic stroke and/or Myocardial Infarction (MI),

4. hypercoagulable state,

5. active malignancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ignatios Ikonomidis

Dr Ignatios Ikonomidis,MD,PhD,FESC Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignatios Ikonomidis

Role: PRINCIPAL_INVESTIGATOR

University of Athens

Locations

Konstantinos Katogiannis

Athens, Attica, Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 31421641 (View on PubMed)

Other Identifiers

esus-endothelium-attikon

Identifier Type: -

Identifier Source: org_study_id