An observational study in Arteriosclerosis, Acute Myocardial Infarction and Cardiovascular Events, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Heinrich-Heine University, Duesseldorf · Observational
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.
Sex-specific differences in the risk profile and outcome of cardiovascular diseases are evident, which are probably due to hormonal factors. Women suffer significantly fewer cardiovascular events than men before menopause, after menopause this relationship seems to reverse. Moreover, outcome is worse in female patients compared to men.
Platelets and leukocytes play an essential role in cardiovascular risk. Nevertheless, the underlying mechanisms of the mechanistic effects of the hormone transition in menopause on leukocytes and platelets have only been insufficiently investigated so far. Moreover, effects of a possible hormone replacement therapy are insufficiently understood with contradictive literature concerning cardiovascular effects.
The aim in this study, is to analyse leukocyte and platelet function in dependence from menopause related changes in hormone levels of estrogen, testosterone, progesterone, LH and FSH. Moreover, hormone replacement therapy will be investigated.
For this purpose, blood samples from male and female patients will be investigated with regard to age and menopause status. The blood samples are analysed by FACS to differentiate the leukocytes and test for inflammatory properties and reactive oxygen species. The monocyte distribution divided according to the surface markers CD14 and CD16 is analysed. In addition, plasma from the patient samples will be used to assess hormone levels in the blood. In addition, patient data such as general laboratory parameters, risk and lifestyle factors are collected and associated with the hormone and lipid levels.
For platelet function analysis, light-transmittance aggregometry, flow cytometry (platelet leukocyte crosstalk, investigation of platelet surface markers for platelet activation and cell-cell-adhesion) will be investigated. Platelets secretory potency will be analysed by ATP-release. Moreover, platelet adhesion will be investigated by collagen-coated flow chambers. Platelet proteomics and RNA sequencing will complement the data in an unbiased approach. In addition in-vitro incubation analyses with estrogen and testosterone will be conducted to investigate hormone replacement therapy effects.
157 studies on the registry are indexed under Arteriosclerosis; 18 are open to participants now.
This study's planned enrollment of 180 is below the median of 280 across 46 observational studies indexed under Arteriosclerosis.
Browse Arteriosclerosis studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female Patients with and without cardiovascular disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 inclusion
Platelet function
measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope
Time frame: single time, up to one day after inclusion
Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L)
measured by flow cytometry (FACS)
Time frame: single time, up to one day after inclusion
Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean]
measured by Flow Cytometry (FACS)
Time frame: single time, up to one day after inclusion
Hormone levels of estrogen
measured by ELISA \[ng/l\]
Time frame: single time, up to one day after inclusion
Hormone levels of testosterone measured by ELISA
measured by ELISA \[ng/l\]
Time frame: single time, up to one day after inclusion
Hormone levels of progesterone
measured by ELISA \[µg/l\]
Time frame: single time, up to one day after inclusion
Hormone levels of follicle stimulating hormone
measured by ELISA \[µg/l\]
Time frame: single time, up to one day after inclusion
Hormone levels of luteinizing hormone
measured by ELISA \[µg/l\]
Time frame: single time, up to one day after inclusion
Questionnaire including lifestyle factors, cardiovascular risk factors
Time frame: single time, up to one day after inclusion
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2022 (actual). Primary completion is estimated for Dec 2025, 45 months after the start.
Of 26 observational studies under Arteriosclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
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