Ischemic StrokeEPCASNCT01289795
Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with first-ever ischemic stroke transferred to our stroke unit
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Inability to give written informed consent
- Psychosis
- Alcohol dependency
- Abuse of illegal drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Center for Stroke Research Berlin
Berlin, State of Berlin, 10117
Thomas Liman, MD, 004930450560643, thomas.liman@charite.de
Thomas Liman, MD
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
- Medical subject headings
- Ischemic Stroke, Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| first-ever ischemic stroke | first-ever ischemic stroke according to the WHO definition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of cEPC
Levels of cEPC (CD34+/CD133+/VEGF2R+/CD31) in % of mononuclear cells using flow cytometry with respect to stroke subtypes.
Measured: <48h, day 4-5, discharge or day 7
Secondary outcomes (2)
Levels of EMP
Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes.
Measured: <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
Measured: <48h, day 4-5,day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Endres, MD, Principal investigator, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289795
- Sponsor's protocol ID
- FF_NCRC_EPC01
- Other IDs
- 2009-010356-97, 2009
- Acronym
- EPCAS
- Status last verified
- Jan 2011
- First submitted
- 3 Feb 2011
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01289795
- Acronym / sponsor ID
- EPCAS / FF_NCRC_EPC01
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| first-ever ischemic stroke | – | –first-ever ischemic stroke according to the WHO definition |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with first-ever ischemic stroke transferred to our stroke unit
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of cEPC
Time frame: <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.
2 secondary outcomes
Levels of EMP
Time frame: <48h, day 4-5, day 7 or discharge
ENDOPAT
Time frame: <48h, day 4-5,day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Endres, MD principal investigator
Center for Stroke Research Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Liman, MD (004930450560643, thomas.liman@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of cEPC (time frame: <48h, day 4-5, discharge or day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2011.