Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

NCT01289795 | Unknown

• 2 other identifiers: FF_NCRC_EPC012009-010356-97
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Levels of EMP

  <48h, day 4-5, day 7 or discharge

• ENDOPAT

  <48h, day 4-5,day 7

Study Arms (1)

first-ever ischemic stroke

first-ever ischemic stroke according to the WHO definition

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Center for Stroke Research Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, PBMC, plasma

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Cerebral Infarction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Matthias Endres, MD

  Center for Stroke Research Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Liman, MD

CONTACT

004930450560643; thomas.liman@charite.de

Matthias Endres, MD

CONTACT

004930450560102; matthias.endres@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 4, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 4, 2011

Record last verified: 2011-01

Locations

DE (1)