Menopause Related Influences on Leukocyte Distribution, Monocyte Function and Platelet Reactivity

NCT05985447 | Recruiting

• 1 other identifier: Hormone
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arteriosclerosis; Acute Myocardial Infarction; Cardiovascular Events; Menopause

Keywords

sex; gender; female; male; menopause; hormone replacement therapy; Atherosclerosis; cardiovascular events; cardiovascular risk

Outcome Measures

Primary Outcomes (3)

• 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

• Platelet function

  measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope

  single time, up to one day after inclusion

• Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L)

  measured by flow cytometry (FACS)

  single time, up to one day after inclusion

Secondary Outcomes (7)

• Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean]

  single time, up to one day after inclusion

• Hormone levels of estrogen

  single time, up to one day after inclusion

• Hormone levels of testosterone measured by ELISA

  single time, up to one day after inclusion

• Hormone levels of progesterone

  single time, up to one day after inclusion

• Hormone levels of follicle stimulating hormone

  single time, up to one day after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female Patients with and without cardiovascular disease

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Lack of written consent to participate in the study
• coagulation disorders

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

prospectively defined blood sampling protocol

MeSH Terms

Conditions

Arteriosclerosis; Coitus; Atherosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Sexual Behavior; Behavior

Study Officials

• Malte Kelm, Prof.

  Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  STUDY CHAIR

Central Study Contacts

Lisa Dannenberg, MD

CONTACT

+492118105315; lisa.dannenberg@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: August 14, 2023
• Study Start: March 7, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)