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Migraine and Endothelial Dysfunction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388699
First Posted: July 7, 2011
Last Update Posted: July 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition
Migraine With Aura

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Migraine and Endothelial Dysfunction

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Endothelial Microparticles [ Time Frame: baseline ]
    Levels of endothelial microparticlel in the peripheral blood using flow cytometry


Secondary Outcome Measures:
  • Levels of circulating Endothelial Progenitor Cells [ Time Frame: baseline ]
    Levels of cEPC (CD34+/CD133+/VGF2R/CD31) in % of mononuclear cells using flow cytometry

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


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
migraine group
female migraineurs with aura
control group
healthy women without headache syndrome

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
female migraineurs from outpatient clinic
Criteria

Inclusion Criteria:

  • migraine with aura
  • age < 50
  • female gender

Exclusion Criteria:

  • severe infectious disease
  • cardiovascular disease (stroke, coronary heart disease, myocardial infarction)
  • vasculitis
  • peripheral artery disease
  • diabetes mellitus
  • pregnancy
  • drug abuse
  • medication: statin, anticoagulation, aspirin, clopidogrel
  • intake of triptans <24h
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388699


Contacts
Contact: Matthias Endres, MD 004930450560102 matthias.endres@charite.de
Contact: Thomas G Liman, MD 004930450560643 thomas.liman@charite.de

Locations
Germany
Center for Stroke Research Berlin Recruiting
Berlin, Germany, 10117
Contact: Thomas G Liman, MD    004930450560643    thomas.liman@charite.de   
Principal Investigator: Matthias Endres, MD         
Sub-Investigator: Thomas G Liman, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Matthias Endres, MD Center for Stroke Research Berlin, Charité Campus Mitte
  More Information

Responsible Party: Center for Stroke Research Berlin, Center for Stroke Research Berlin (Matthias Endres)
ClinicalTrials.gov Identifier: NCT01388699     History of Changes
Other Study ID Numbers: FF_NCRC_Migraine&ED
First Submitted: July 5, 2011
First Posted: July 7, 2011
Last Update Posted: July 7, 2011
Last Verified: June 2011

Keywords provided by Charite University, Berlin, Germany:
Migraine with aura

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases