Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to determine whether levels of circulating endothelial progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.

Detailed Description
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Endothelial dysfunction is a key component of atherosclerosis which contributes to the development of cardio- and cerebrovascular diseases. However, endothelial dysfunction (ED) is not established as a risk factor for ischemic stroke. As a novelty the proposed trial investigates the following variety of indirect markers of endothelial function in acute ischemic stroke: circulating endothelial progenitor cells (EPC), endothelial microparticles (EMP), ENDOPAT (RH- PAT ratio) in two regards: time after ischemic events (< 48h, Days 4-5, day 7 or at discharge) etiological stroke subtypes It is not known whether these parameters are changed after acute cerebral ischemia and could possibly serve as specific target for treatment.

Official Title
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Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Conditions
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Ischemic Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with first ever ischemic stroke TIA, or transient symptoms with infarction (TSI) Age > or = 18 years old within 24 hours after onset Written informed consent to participate No evidence for dysphagia Exclusion Criteria: Malignant hematopoietic disease (e.g. leukemia), severe systemic infections, severe immunological disease, renal or hepatic failure Pancreatitis, cholecystolithiasis, intestinal malabsorption Lactose intolerance Increased risk of aspiration Pregnancy Life expectancy less than 12 months Inability to give written informed consent Psychosis Alcohol dependency Abuse of illegal drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| first-ever ischemic stroke<br>first-ever ischemic stroke according to the WHO definition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of cEPC | Levels of cEPC (CD34+/CD133+/VEGF2R+/CD31) in % of mononuclear cells using flow cytometry with respect to stroke subtypes. | <48h, day 4-5, discharge or day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of EMP | Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes. | <48h, day 4-5, day 7 or discharge | 
| ENDOPAT | Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function | <48h, day 4-5,day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases