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

National and Kapodistrian University of Athens

Status: Active, not recruiting

Conditions: Endothelial Dysfunction; Embolic Stroke of Undetermined Source

Study type: Observational

Funder types: Other

Identifiers

NCT03609437

esus-endothelium-attikon

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
6. severe chronic kidney disease (eGFR<30 ml/minute). These exclusion criteria are applied to both patients and control subjects.

Trial design

215 participants in 5 patient groups

ESUS patients

Description:

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

Controls

Description:

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

Lacunar stroke patients

Description:

Acute ischemic stroke patients satisfying lacunar stroke diagnostic criteria

Cardioembolic stroke patients

Description:

Acute ischemic stroke patients satisfying cardioembolic stroke diagnostic criteria

Atherosclerotic stroke patients

Description:

Acute ischemic stroke patients satisfying atherosclerotic stroke diagnostic criteria