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Clinical Trials/NCT01289795
NCT01289795
Unknown
Not Applicable

Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Charite University, Berlin, Germany1 site in 1 country30 target enrollmentJuly 2010
ConditionsIschemic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Charite University, Berlin, Germany
Enrollment
30
Locations
1
Primary Endpoint
Levels of cEPC
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
June 2012
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Levels of cEPC

Time Frame: <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 Outcomes

  • Levels of EMP(<48h, day 4-5, day 7 or discharge)
  • ENDOPAT(<48h, day 4-5,day 7)

Study Sites (1)

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