Clinical trial NCT01388699: Migraine and Endothelial Dysfunction
Official title: Migraine and Endothelial Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine With Aura
Keywords: Migraine with aura
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female migraineurs from outpatient clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial Microparticles
timeFrame: baseline
Secondary outcomes:
measure: Levels of circulating Endothelial Progenitor Cells
timeFrame: baseline
measure: Digital pulse volume change
timeFrame: baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Stroke Research Berlin
Study officials:
affiliation: Center for Stroke Research Berlin, Charité Campus Mitte
name: Thomas Liman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Liman TG, Bachelier-Walenta K, Neeb L, Rosinski J, Reuter U, Bohm 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.
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.