Menopause Related Influences on Leukocyte Distribution, Monocyte Function and Platelet Reactivity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
Women and men show marked differences in cardiovascular risk profile and outcome. Women experience fewer cardiovascular events than men before menopause, but this relationship seems to reverse at menopause. These disparities are probably due to hormonal factors, especially the female sex hormone estrogen seems to have a protective influence on the development of atherosclerotic plaques premenopausal.
The underlying mechanisms of the effect of estrogens on the vessel wall are still insufficiently investigated. In this study, menopause related effects on leukocyte distribution and function as well on platelets and their aggregational response will be evaluated.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years
Male, female, diverse patients with current treatment in the Department of Cardiology, Pneumology and Angiology.
Persons who are able to understand and follow the instructions of the study staff
Written informed consent
Disqualifiers
Age < 18 years
Lack of written consent to participate in the study
coagulation disorders
Trial population
Male and female Patients with and without cardiovascular disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Leukocyte distribution measured by flow cytometry
CD45 (Leukocytes), CD3 (T-cells), CD14 (Monocytes), CD16 (Granulocytes), CD19 (B-cells)
Time frame
single time, up to one day after inclusion2
Platelet function
measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope
Time frame
single time, up to one day after inclusion3
Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L)
measured by flow cytometry (FACS)
Time frame
single time, up to one day after inclusionSecondary outcomes
1
Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean]
measured by Flow Cytometry (FACS)
Time frame
single time, up to one day after inclusion2
Hormone levels of estrogen
measured by ELISA \[ng/l\]
Time frame
single time, up to one day after inclusion3
Hormone levels of testosterone measured by ELISA
measured by ELISA \[ng/l\]
Time frame
single time, up to one day after inclusion4
Hormone levels of progesterone
measured by ELISA \[µg/l\]
Time frame
single time, up to one day after inclusionSponsors and contacts
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Source ClinicalTrials.gov