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

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ClinicalTrials.gov Identifier: NCT01289795
Recruitment Status : Unknown
Verified January 2011 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : February 4, 2011
Last Update Posted : February 4, 2011
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date February 3, 2011
First Posted Date February 4, 2011
Last Update Posted Date February 4, 2011
Study Start Date July 2010
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2011)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 3, 2011)
  • Levels of EMP [ Time Frame: <48h, day 4-5, day 7 or discharge ]
    Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes.
  • ENDOPAT [ Time Frame: <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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
Official Title Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood, serum, PBMC, plasma
Sampling Method Non-Probability Sample
Study Population Patients with first-ever ischemic stroke transferred to our stroke unit
Condition Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts first-ever ischemic stroke
first-ever ischemic stroke according to the WHO definition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 3, 2011)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01289795
Other Study ID Numbers FF_NCRC_EPC01
2009-010356-97 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Matthias Endres, MD, Center for Stroke Research Berlin
Study Sponsor Charite University, Berlin, Germany
Collaborators Not Provided
Investigators
Principal Investigator: Matthias Endres, MD Center for Stroke Research Berlin
PRS Account Charite University, Berlin, Germany
Verification Date January 2011