Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01289795

Acronym

EPCAS

Enrollment

Registered

2011-02-04

Start date

2010-07-31

Completion date

2012-06-30

Last updated

2011-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Levels of cEPC	<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

Measure	Time frame	Description
Levels of EMP	<48h, day 4-5, day 7 or discharge	Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes.
ENDOPAT	<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

Countries

Germany

Contacts

Primary ContactThomas Liman, MD

thomas.liman@charite.de004930450560643

Backup ContactMatthias Endres, MD

matthias.endres@charite.de004930450560102

Outcome results