G44.0
Conditions
Interventions
Group 1: Patients with episodic cluster headache
In this monocentric case-control study, markers of endothelial dysfunction will be assessed at two time points in patients with episodic cluster head
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Key inclusion criteria for patients with episodic cluster headache: • Documented history of episodic cluster headache for = 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) • No preventive treatment for cluster headache at least 3 months before screening, or stable treatment = 3 months before screening Key inclusion criteria for patients with chronic cluster headache: • Documented history of chronic cluster headache for = 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) • No preventive treatment for cluster headache at least 3 months before screening, or stable treatment = 3 months before screening Key inclusion criteria for healthy controls: • No diagnosis or history of any primary or secondary headache disorders according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), except for infrequent episodic tension-type headache (=5 days per month)
Exclusion criteria
Exclusion criteria: Key exclusion criteria for patients with episodic or chronic cluster headache: • Diagnosis or history of other primary headache disorders according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), except for infrequent episodic tension-type headache (=5 days per month) • Pregnancy or lactation • Diagnosis of severe inflammatory disease (infectious, rheumatic) • Diagnosis or history of cardiovascular disease (including stroke, coronary artery disease, myocardial infarction, severe valvular heart disease, decompensated heart failure, peripheral arterial disease, Raynaud’s disease) • Cardiovascular risk factors: Diabetes mellitus, arterial hypertension, obesity (body mass index > 30 kg/m2) • Regular use of vasoactive medication, except for verapamil as preventive treatment and triptans as acute medication • Other disease that, in the opinion of the study physician after evaluation of benefit and risk, is not compatible with study participation Key exclusion criteria for healthy controls: • Pregnancy or lactation • Diagnosis of severe inflammatory disease (infectious, rheumatic) • Diagnosis or history of cardiovascular disease (including stroke, coronary artery disease, myocardial infarction, severe valvular heart disease, decompensated heart failure, peripheral arterial disease, Raynaud’s disease) • Cardiovascular risk factors: Diabetes mellitus, arterial hypertension, obesity (body mass index > 30 kg/m2) • Regular use of vasoactive medication • Diagnosis or history of severe psychiatric disorder, drug abuse, alcohol abuse • Other disease that, in the opinion of the study physician after evaluation of benefit and risk, is not compatible with study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the level of endothelial microvesicles compared between patients with cluster headache (episodic/chronic) and healthy control subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: 1. levels of other established blood-based endothelial biomarkers (e.g., hs-CRP, SDF-1 alpha) compared between patients with cluster headache (episodic/chronic) and healthy control subjects 2. the aortic augmentation index as an indicator of arterial stiffness compared between patients with cluster headache (episodic/chronic) and healthy control subjects 3. carotid-femoral pulse wave velocity as an indicator of arterial compared between patients with cluster headache (episodic/chronic) and healthy control subjects Selected exploratory hypotheses are: 1. That levels of endothelial microvesicles are elevated in patients with episodic cluster headache in the active phase compared to remission. 2. That levels of other established blood-based endothelial biomarkers (e.g., hs-CRP, SDF-1 alpha) are altered in patients with episodic cluster headache in the active phase compared to remission. 3. That the aortic augmentation index is elevated in patients with episodic cluster headache in the active phase compared to remission. 4. That carotid-femoral pulse wave velocity is elevated in patients with episodic cluster headache in the active phase compared to remission. 5. That levels of blood-based biomarkers correlate with markers of arterial stiffness in patients with cluster headache. 6. That levels of endothelial microvesicles in patients with chronic cluster headache do not change within 6 months. 7. That levels of hs-CRP and SDF-1 alpha in patients with chronic cluster headache do not change within 6 months. 8. That the aortic augmentation index in patients with chronic cluster headache does not change within 6 months. 9. That carotid-femoral pulse wave velocity in patients with chronic cluster headache does not change within 6 months. | — |
Countries
Germany
Contacts
Public ContactKristin Sophie Lange
Charité - Universitätsmedizin Berlin, Klinik für Neurologie
Outcome results
None listed