- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289795
Endothelial Function and Progenitor Cells in Acute Ischemic Stroke (EPCAS)
Study Overview
Status
Conditions
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:
- time after ischemic events (< 48h, Days 4-5, day 7 or at discharge)
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Thomas Liman, MD
- Phone Number: 004930450560643
- Email: thomas.liman@charite.de
Study Contact Backup
- Name: Matthias Endres, MD
- Phone Number: 004930450560102
- Email: matthias.endres@charite.de
Study Locations
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-
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Berlin, Germany, 10117
- Recruiting
- Center for Stroke Research Berlin
-
Contact:
- Thomas Liman, MD
- Phone Number: 004930450560643
- Email: thomas.liman@charite.de
-
Principal Investigator:
- Thomas Liman, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
first-ever ischemic stroke
first-ever ischemic stroke according to the WHO definition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
<48h, day 4-5, discharge or day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
<48h, day 4-5, day 7 or discharge
|
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
|
<48h, day 4-5,day 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthias Endres, MD, Center for Stroke Research Berlin
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FF_NCRC_EPC01
- 2009-010356-97 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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