ArteriosclerosisNCT05985447
Menopause Related Influences on Leukocyte Distribution, Monocyte Function and Platelet Reactivity
An observational study of Arteriosclerosis and Acute Myocardial Infarction, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arteriosclerosis, Acute Myocardial Infarction, Cardiovascular Events
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female Patients with and without cardiovascular disease
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Lack of written consent to participate in the study
- coagulation disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Lisa Dannenberg, MD, +492118105315, lisa.dannenberg@med.uni-duesseldorf.de
Clinical Trial Unit, +4921181105315, ctu@med.uni-duesseldorf.de
About this study
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.
Read the detailed description
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.
- Keywords
- sex, gender, female, male, menopause, hormone replacement therapy, Atherosclerosis, cardiovascular events, cardiovascular risk
- Medical subject headings
- Arteriosclerosis, Coitus, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte distribution measured by flow cytometry
CD45 (Leukocytes), CD3 (T-cells), CD14 (Monocytes), CD16 (Granulocytes), CD19 (B-cells)
Measured: single time, up to one day after inclusion
Platelet function
measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope
Measured: single time, up to one day after inclusion
Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L)
measured by flow cytometry (FACS)
Measured: single time, up to one day after inclusion
Secondary outcomes (7)
Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean]
measured by Flow Cytometry (FACS)
Measured: single time, up to one day after inclusion
Hormone levels of estrogen
measured by ELISA [ng/l]
Measured: single time, up to one day after inclusion
Hormone levels of testosterone measured by ELISA
measured by ELISA [ng/l]
Measured: single time, up to one day after inclusion
Hormone levels of progesterone
measured by ELISA [µg/l]
Measured: single time, up to one day after inclusion
Hormone levels of follicle stimulating hormone
measured by ELISA [µg/l]
Measured: single time, up to one day after inclusion
Hormone levels of luteinizing hormone
measured by ELISA [µg/l]
Measured: single time, up to one day after inclusion
Questionnaire including lifestyle factors, cardiovascular risk factors
Measured: single time, up to one day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start7 Mar 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985447
- Sponsor's protocol ID
- Hormone
- Status last verified
- Aug 2023
- First submitted
- 14 Apr 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause Related Influences on Leukocyte Distribution, Monocyte Function and Platelet Reactivity
- ClinicalTrials.gov ID
- NCT05985447
- Acronym / sponsor ID
- Hormone
- Keywords
- sex, gender, female, male, menopause, hormone replacement therapy, Atherosclerosis, cardiovascular events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female Patients with and without cardiovascular disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Lack of written consent to participate in the study
- coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leukocyte distribution measured by flow cytometry
Time frame: single time, up to one day after inclusion
CD45 (Leukocytes), CD3 (T-cells), CD14 (Monocytes), CD16 (Granulocytes), CD19 (B-cells)
Platelet function
Time frame: single time, up to one day after inclusion
measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope
Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L)
Time frame: single time, up to one day after inclusion
measured by flow cytometry (FACS)
7 secondary outcomes
Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean]
Time frame: single time, up to one day after inclusion
Hormone levels of estrogen
Time frame: single time, up to one day after inclusion
Hormone levels of testosterone measured by ELISA
Time frame: single time, up to one day after inclusion
Hormone levels of progesterone
Time frame: single time, up to one day after inclusion
Hormone levels of follicle stimulating hormone
Time frame: single time, up to one day after inclusion
Hormone levels of luteinizing hormone
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malte Kelm, Prof. study chair
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriosclerosis and Acute Myocardial Infarction, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Dannenberg, MD (+492118105315, lisa.dannenberg@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte distribution measured by flow cytometry (time frame: single time, up to one day after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.