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Migraine and Endothelial Dysfunction

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. Identifier: NCT01388699
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : July 18, 2018
Information provided by (Responsible Party):
Thomas Liman, Charite University, Berlin, Germany

Brief 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.

Condition or disease
Migraine With Aura

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Migraine and Endothelial Dysfunction
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

migraine group
female migraineurs with aura
control group
healthy women without headache syndrome

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

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

  2. 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

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

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

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 identifier (NCT number): NCT01388699

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Center for Stroke Research Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Thomas Liman, MD Center for Stroke Research Berlin, Charité Campus Mitte

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Responsible Party: Thomas Liman, MD MSC, Charite University, Berlin, Germany Identifier: NCT01388699     History of Changes
Other Study ID Numbers: FF_NCRC_Migraine&ED
First Posted: July 7, 2011    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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

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