Endothelial Function and Progenitor Cells in Acute Ischem... | NCT01289795

Studies
Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

NCT01289795

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Feb 4, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-010356-97	EudraCT Number

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Feb 3, 2011

First Submission Date that Met QC Criteria

Feb 3, 2011

First Posted Date

Feb 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2011

Last Update Posted Date

Feb 4, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
first-ever ischemic stroke		first-ever ischemic stroke according to the WHO definition

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
ENDOPAT	Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Liman, MD	Contact	004930450560643		thomas.liman@charite.de
Matthias Endres, MD	Contact	004930450560102		matthias.endres@charite.de

Overall Officials

Name	Affiliation	Role
Matthias Endres, MD	Center for Stroke Research Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Stroke Research Berlin	Recruiting	Berlin	State of Berlin	10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke
D002544	Cerebral Infarction
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D020520	Brain Infarction

Browse Leaves

Not provided

Browse Branches

Not provided