Endothelial Dysfunction Clinical Trial
— ESUSOfficial title:
Impaired Endothelial Glycocalyx Integrity and Arterial Elastic Properties in Patients With Embolic Stroke of Undetermined Source (ESUS)
Verified date | July 2018 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cardioembolism is a postulated mechanism of an embolic stroke of undetermined source (ESUS). 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 and age- and sex-adjusted healthy individuals.
Status | Completed |
Enrollment | 124 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: The clinical entity of ESUS is defined according to the criteria proposed by the Cryptogenic Stroke/ESUS International Working Group: (1) stroke visualized by computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (Lacunar defined as a subcortical infarct 1.5 cm or 2.0 cm on MRI diffusion images in largest dimension), (2) absence of extra-cranial or intra-cranial atherosclerosis causing >50% luminal stenosis or occlusion of arteries supplying the area of ischemia (Requires extra-cranial and intra-cranial arterial imaging using sonography, computed tomography angiography, or magnetic resonance angiography of the relevant arteries) (3) no major-risk cardioembolic source of embolism by history, electrocardiography, echocardiography and >24 h of cardiac rhythm monitoring [Permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intra-cardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate/severe mitral stenosis, recent (<4 weeks) myocardial infarction, valvular vegetations, or infective endocarditis] (4) no other specific cause of ischemic stroke identified (e.g. arteritis, dissection, migraine/vasospasm, drug abuse) Exclusion Criteria 1. factors associated with a medium or high risk for thrombus formation in patients with stroke, such as the presence of aortic or mitral valvular prostheses, history of atrial fibrillation (AF) or atrial flutter, known or suspected cardiomyopathy, infective endocarditis, atrial septal defect and intracardiac tumor or thrombus 2. potential confounders in the measurement of left atrial (LA) mechanical function, including the presence of significant (>50% luminal) coronary artery stenosis, previous myocardial infarction or regional wall motion abnormality, prior administration of cardiotoxic chemotherapeutic agents, sick sinus syndrome, any valvular lesion of >2+ severity and pregnancy. These exclusion criteria are applied to both patients and control subjects. |
Country | Name | City | State |
---|---|---|---|
Greece | Konstantinos Katogiannis | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of endothelial glycocalyx thickness between patients with embolic stroke of undetermined source (ESUS) 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) and controls. | Baseline | |
Secondary | Comparison of arterial stiffness between patients with embolic stroke of undetermined source (ESUS) and controls. | Investigators aim to evaluate arterial stiffness by pulse wave velocity (PWV,m/sec) using tonometry in patients with embolic stroke of undetermined source (ESUS) and controls. | Baseline | |
Secondary | Assessment of left ventricular global longitudinal strain (GLS, %) in patients with embolic stroke of undetermined source (ESUS) and controls. | Investigators plan to assess left ventricular in patients with embolic stroke of undetermined source (ESUS) and controls. | Baseline | |
Secondary | Serum malondialdehyde levels in patients with embolic stroke of undetermined source (ESUS) and controls. | Investigators plan to compare serum malondialdehyde levels in patients with embolic stroke of undetermined source (ESUS) and controls. | Baseline |
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