Endothelial Dysfunction in Cluster Headache

Recruiting

• Conditions: G44.0; Cluster headache syndrome

• Registration Number: DRKS00031899
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the level of endothelial microvesicles compared between patients with cluster headache (episodic/chronic) and healthy control subjects.