Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

• Conditions: Ischemic Stroke

• Registration Number: NCT01289795
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-07
• Status Verified: 2011-01
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Last Update Submitted: 2011-02-03
• Study First Posted: 2011-02-04
• Last Update Posted: 2011-02-04
• Primary Completion: 2011-12
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for Stroke Research Berlin; 🇩🇪 Berlin, Germany