Migraine With AuraNCT01388699
Migraine and Endothelial Dysfunction
An observational study of Migraine With Aura, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Recently, there is evidence that endothelial activation and dysfunction are associated with migraine, especially in female migraineurs with aura. Our objectives were to determine whether novel endothelial function markers are altered in female migraineurs with aura compared to age-matched controls. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2011
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female migraineurs from outpatient clinic
Who may be able to join
- migraine with aura
- age < 50
- female gender
Who cannot join
- severe infectious disease
- cardiovascular disease (stroke, coronary heart disease, myocardial infarction)
- vasculitis
- peripheral artery disease
- diabetes mellitus
- pregnancy
Show all 9Show fewer
- drug abuse
- medication: statin, anticoagulation, aspirin, clopidogrel
- intake of triptans <24h
Trial locations and contacts
1 site in 1 country.
About this study
Recently, there is evidence that endothelial activation and dysfunction are associated with migraine, especially in female migraineurs with aura. Our objectives were to determine whether novel endothelial function markers are altered in female migraineurs with aura compared to age-matched controls.
Read the detailed description
Our objectives were to determine whether novel endothelial function methods and novel markers of endothelial activation are associated with migraine in female migraineurs with aura.
Migraine is an independent risk factor for stroke, especially in young women with aura symptoms. Endothelial dysfunction is a risk factor for cardiovascular diseases. Recent studies suggest that there is a link between migraine with aura and endothelial activation, dysfunction and impaired vascular reactivity.
In this case-control study the investigators examine several novel biomarkers of endothelial function such as endothelial progenitor cells and endothelial microparticles as well as novel methods such as reactive hyperemic peripheral arterial tonometry in female migraineurs with aura and age-matched controls.
- Conditions
- Migraine With Aura
- Keywords
- Migraine with aura
- Medical subject headings
- Migraine with Aura
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 |
|---|---|---|
| migraine group | female migraineurs with aura | |
| control group | healthy women without headache syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Microparticles
Levels of endothelial microparticlel in the peripheral blood using flow cytometry
Measured: baseline
Secondary outcomes (2)
Levels of circulating Endothelial Progenitor Cells
Levels of cEPC (CD34+/CD133+/VGF2R/CD31) in % of mononuclear cells using flow cytometry
Measured: baseline
Digital pulse volume change
Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Liman, Charite University, Berlin, Germany
- Investigators
- Thomas Liman, MD, Principal investigator, Center for Stroke Research Berlin, Charité Campus Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388699
- Sponsor's protocol ID
- FF_NCRC_Migraine&ED
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2011
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Liman TG, Neeb L, Rosinski J, Wellwood I, Reuter U, Doehner W, Heuschmann PU, Endres M. Peripheral endothelial function and arterial stiffness in women with migraine with aura: a case-control study. Cephalalgia. 2012 Apr;32(6):459-66. doi: 10.1177/0333102412444014. Epub 2012 Apr 20.
PubMed 22523187Liman TG, Bachelier-Walenta K, Neeb L, Rosinski J, Reuter U, Bohm M, Endres M. Circulating endothelial microparticles in female migraineurs with aura. Cephalalgia. 2015 Feb;35(2):88-94. doi: 10.1177/0333102414529671. Epub 2014 Apr 8.
PubMed 24715500Liman TG, Neeb L, Rosinski J, Reuter U, Endres M. Stromal Cell-Derived Factor-1 Alpha Is Decreased in Women With Migraine With Aura. Headache. 2016 Sep;56(8):1274-9. doi: 10.1111/head.12839. Epub 2016 May 30.
PubMed 27238143
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine and Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT01388699
- Acronym / sponsor ID
- FF_NCRC_Migraine&ED
- Conditions
- Migraine With Aura
- Keywords
- Migraine with aura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jul 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.
Recently, there is evidence that endothelial activation and dysfunction are associated with migraine, especially in female migraineurs with aura. Our objectives were to determine whether novel endothelial function markers are altered in female migraineurs with aura compared to age-matched controls.
Detailed description
Our objectives were to determine whether novel endothelial function methods and novel markers of endothelial activation are associated with migraine in female migraineurs with aura.
Migraine is an independent risk factor for stroke, especially in young women with aura symptoms. Endothelial dysfunction is a risk factor for cardiovascular diseases. Recent studies suggest that there is a link between migraine with aura and endothelial activation, dysfunction and impaired vascular reactivity.
In this case-control study the investigators examine several novel biomarkers of endothelial function such as endothelial progenitor cells and endothelial microparticles as well as novel methods such as reactive hyperemic peripheral arterial tonometry in female migraineurs with aura and age-matched controls.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| migraine group | – | –female migraineurs with aura |
| control group | – | –healthy women without headache syndrome |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female migraineurs from outpatient clinic
Key inclusion criteria (3 listed)
- migraine with aura
- age < 50
- female gender
Key exclusion criteria (9 listed)
- severe infectious disease
- cardiovascular disease (stroke, coronary heart disease, myocardial infarction)
- vasculitis
- peripheral artery disease
- diabetes mellitus
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
Endothelial Microparticles
Time frame: baseline
Levels of endothelial microparticlel in the peripheral blood using flow cytometry
2 secondary outcomes
Levels of circulating Endothelial Progenitor Cells
Time frame: baseline
Digital pulse volume change
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 22523187Liman TG, Neeb L, Rosinski J, Wellwood I, Reuter U, Doehner W, Heuschmann PU, Endres M. Peripheral endothelial function and arterial stiffness in women with migraine with aura: a case-control study. Cephalalgia. 2012 Apr;32(6):459-66. doi: 10.1177/0333102412444014. Epub 2012 Apr 20.
- Background: PubMed 24715500Liman TG, Bachelier-Walenta K, Neeb L, Rosinski J, Reuter U, Bohm M, Endres M. Circulating endothelial microparticles in female migraineurs with aura. Cephalalgia. 2015 Feb;35(2):88-94. doi: 10.1177/0333102414529671. Epub 2014 Apr 8.
- Background: PubMed 27238143Liman TG, Neeb L, Rosinski J, Reuter U, Endres M. Stromal Cell-Derived Factor-1 Alpha Is Decreased in Women With Migraine With Aura. Headache. 2016 Sep;56(8):1274-9. doi: 10.1111/head.12839. Epub 2016 May 30.
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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.
Thomas Liman, MD principal investigator
Center for Stroke Research Berlin, Charité Campus Mitte
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 Migraine With Aura, 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 18 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Microparticles (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388699, which also lists 3 linked publications.
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 18 Jul 2018.