Migraine and Endothelial Dysfunction

NCT ID: NCT01388699

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine With Aura

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

migraine group

female migraineurs with aura

No interventions assigned to this group

control group

healthy women without headache syndrome

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Liman

MD MSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Liman, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Stroke Research Berlin, Charité Campus Mitte

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Stroke Research Berlin

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22523187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24715500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27238143 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FF_NCRC_Migraine&ED

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Migraine and Infertility
NCT03831659 COMPLETED