Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— EPCAS  

Official title:

Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01289795
• Other study ID #: FF_NCRC_EPC01
• Secondary ID: 2009-010356-97
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2011
• Last updated: February 3, 2011
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2011
• Source: Charite University, Berlin, Germany
• Contact: Thomas Liman, MD
• Phone: 004930450560643
• Email: thomas.liman[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of cEPC	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	No
Secondary	Levels of EMP	Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes.	<48h, day 4-5, day 7 or discharge	No
Secondary	ENDOPAT	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	No