Endothelial Function and Progenitor Cells in Acute Ischemic Stroke (EPCAS)

Charité University Medicine Berlin

Status: Unknown

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01289795

FF_NCRC_EPC01

2009-010356-97 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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:

1. time after ischemic events (< 48h, Days 4-5, day 7 or at discharge)
2. 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

first-ever ischemic stroke

Description:

first-ever ischemic stroke according to the WHO definition