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OpenTrials
Completed

NCT Number: NCT01388699

Migraine and Endothelial Dysfunction

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Center for Stroke Research Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Endothelial Microparticles

    Time frame: baseline

    Levels of endothelial microparticlel in the peripheral blood using flow cytometry

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 7, 2011
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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