Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

NCT ID: NCT01289795

Last Updated: 2011-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

first-ever ischemic stroke

first-ever ischemic stroke according to the WHO definition

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Center for Stroke Research Berlin

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthias Endres, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Stroke Research Berlin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Stroke Research Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas Liman, MD

Role: CONTACT

004930450560643

Matthias Endres, MD

Role: CONTACT

004930450560102

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thomas Liman, MD

Role: primary

004930450560643

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-010356-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FF_NCRC_EPC01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Atherosclerosis and Acute Ischemic Stroke Study
NCT03685006 ACTIVE_NOT_RECRUITING