Migraine and Endothelial Dysfunction

Migraine With Aura Clinical Trial

Official title:

Migraine and Endothelial Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388699
• Other study ID #: FF_NCRC_Migraine&ED
• Status: Completed
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Liman TG, Bachelier-Walenta K, Neeb L, Rosinski J, Reuter U, Böhm M, Endres M. Circulating endothelial microparticles in female migraineurs with aura. Cephalalgia. 2015 Feb;35(2):88-94. doi: 10.1177/0333102414529671. Epub 2014 Apr 8. — View Citation

Liman TG, Neeb L, Rosinski J, Reuter U, Endres M. Stromal Cell-Derived Factor-1 Alpha Is Decreased in Women With Migraine With Aura. Headache. 2016 Sep;56(8):1274-9. doi: 10.1111/head.12839. Epub 2016 May 30. — View Citation

Liman TG, Neeb L, Rosinski J, Wellwood I, Reuter U, Doehner W, Heuschmann PU, Endres M. Peripheral endothelial function and arterial stiffness in women with migraine with aura: a case-control study. Cephalalgia. 2012 Apr;32(6):459-66. doi: 10.1177/0333102412444014. Epub 2012 Apr 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Microparticles	Levels of endothelial microparticlel in the peripheral blood using flow cytometry	baseline
Secondary	Levels of circulating Endothelial Progenitor Cells	Levels of cEPC (CD34+/CD133+/VGF2R/CD31) in % of mononuclear cells using flow cytometry	baseline
Secondary	Digital pulse volume change	Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function	baseline