Migraine and Endothelial Dysfunction

July 16, 2018 updated by: Thomas Liman, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Center for Stroke Research Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

female migraineurs from outpatient clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Microparticles
Time Frame: baseline
Levels of endothelial microparticlel in the peripheral blood using flow cytometry
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of circulating Endothelial Progenitor Cells
Time Frame: baseline
Levels of cEPC (CD34+/CD133+/VGF2R/CD31) in % of mononuclear cells using flow cytometry
baseline
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Thomas Liman, MD, Center for Stroke Research Berlin, Charité Campus Mitte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (ESTIMATE)

July 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF_NCRC_Migraine&ED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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