Acute Myocardial Infarction Clinical Trial
Official title:
Menopause Related Influences on Leukocyte Distribution, Monocyte Function and Platelet Reactivity
NCT number | NCT05985447 |
Other study ID # | Hormone |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 7, 2022 |
Est. completion date | December 2026 |
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Age < 18 years - Lack of written consent to participate in the study - coagulation disorders |
Country | Name | City | State |
---|---|---|---|
Germany | University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine | Düsseldorf |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leukocyte distribution measured by flow cytometry | CD45 (Leukocytes), CD3 (T-cells), CD14 (Monocytes), CD16 (Granulocytes), CD19 (B-cells) | single time, up to one day after inclusion | |
Primary | Platelet function | measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope | single time, up to one day after inclusion | |
Primary | Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L) | measured by flow cytometry (FACS) | single time, up to one day after inclusion | |
Secondary | Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean] | measured by Flow Cytometry (FACS) | single time, up to one day after inclusion | |
Secondary | Hormone levels of estrogen | measured by ELISA [ng/l] | single time, up to one day after inclusion | |
Secondary | Hormone levels of testosterone measured by ELISA | measured by ELISA [ng/l] | single time, up to one day after inclusion | |
Secondary | Hormone levels of progesterone | measured by ELISA [µg/l] | single time, up to one day after inclusion | |
Secondary | Hormone levels of follicle stimulating hormone | measured by ELISA [µg/l] | single time, up to one day after inclusion | |
Secondary | Hormone levels of luteinizing hormone | measured by ELISA [µg/l] | single time, up to one day after inclusion | |
Secondary | Questionnaire including lifestyle factors, cardiovascular risk factors | single time, up to one day after inclusion |
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