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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01289795
First received: February 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Levels of cEPC [ Time Frame: <48h, day 4-5, discharge or day 7 ] [ Designated as safety issue: No ]
    Levels of cEPC (CD34+/CD133+/VEGF2R+/CD31) in % of mononuclear cells using flow cytometry with respect to stroke subtypes.


Secondary Outcome Measures:
  • Levels of EMP [ Time Frame: <48h, day 4-5, day 7 or discharge ] [ Designated as safety issue: No ]
    Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes.

  • ENDOPAT [ Time Frame: <48h, day 4-5,day 7 ] [ Designated as safety issue: No ]
    Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function


Biospecimen Retention:   Samples Without DNA

whole blood, serum, PBMC, plasma


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
first-ever ischemic stroke
first-ever ischemic stroke according to the WHO definition

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with first-ever ischemic stroke transferred to our stroke unit

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    
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289795

Contacts
Contact: Thomas Liman, MD 004930450560643 thomas.liman@charite.de
Contact: Matthias Endres, MD 004930450560102 matthias.endres@charite.de

Locations
Germany
Center for Stroke Research Berlin Recruiting
Berlin, Germany, 10117
Contact: Thomas Liman, MD    004930450560643    thomas.liman@charite.de   
Principal Investigator: Thomas Liman, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Matthias Endres, MD Center for Stroke Research Berlin
  More Information

No publications provided

Responsible Party: Matthias Endres, MD, Center for Stroke Research Berlin
ClinicalTrials.gov Identifier: NCT01289795     History of Changes
Other Study ID Numbers: FF_NCRC_EPC01, 2009-010356-97
Study First Received: February 3, 2011
Last Updated: February 3, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014