Migraine and Endothelial Dysfunction

Completed

• Conditions: Migraine With Aura

• Registration Number: NCT01388699
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-07
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial Microparticles	baseline	Levels of endothelial microparticlel in the peripheral blood using flow cytometry

Secondary Outcome Measures

Name	Time	Method
Levels of circulating Endothelial Progenitor Cells	baseline	Levels of cEPC (CD34+/CD133+/VGF2R/CD31) in % of mononuclear cells using flow cytometry
Digital pulse volume change	baseline	Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function

Trial Locations

Locations (1)

Center for Stroke Research Berlin; 🇩🇪 Berlin, Germany