Cardiovascular disease profiles and their known and exploratorily describable risk factors.
Conditions
Interventions
Group 1: This is a single-arm, longitudinal, prospective observational study focusing on the occurrence of established and new risk factors for cardiovascular disease in subjects from the general popu
Sponsors
Charité Universitätsmedizin Berlin / Friede Springer Cardiovascular Prevention Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Informed consent capacity Good proficiency in German, both spoken and written Health insurance
Exclusion criteria
Exclusion criteria: Life expectancy (<6 months) Refusal of blood sampling Acute cardiac decompensation (<6 months) Treatable psychiatric disorders (acute severe depressive episode) Acute dialysis Current chemotherapy / radiation (<6 months) Pregnant & post-partum (mothers only after weaning) Post-organ transplantation status (recipient) Chronic and acute inflammatory bowel diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Background: In the Heart-Health Study, there are no predefined, comparable groups before the study. The goal is to identify new preclinical risk factors and their combinations for cardiovascular diseases across various age groups. Risk clustering, or the description of individual clusters, is an outcome of the study. The occurrence of individual “classic” risk factors is well-known in the population, but there is insufficient data to describe these clusters before conducting the study. Additionally, our observational profile also considers socio-psychological and cognitive parameters (such as self-perception of health, motivation) and modern imaging parameters (e.g., perivascular inflammation). Together, there is no information on how established and new parameters cluster in the Berlin population. The focus of this study is an individual and holistic observation of the course and interactions of preclinical factors that may either promote or minimize the onset of cardiovascular diseases. The description of the desired risk clusters is based on the comprehensive collection of potential preclinical risk factors. These observations and analyses serve to create a more systematic understanding of the clustering of early risk factors in the adult population of Berlin throughout the lifespan. This observation and systematization form the basis for research into cardiovascular disease prevention. The aim is to associate new predictors, such as biomarkers, with preclinical and classic CVD outcomes. Objective 1: The individual cardiovascular risk profile will be assessed and described based on physical (including molecular, cellular, functional, structural), mental, and socio-economic conditions of the participants. Objective 2: Based on the individual risk profiles, "clusters" (i.e., groups of individuals with similar risk profiles) will be described (i.e., cross-sectionally at the time of enrollment in the study). Objective 3:The risk development of individuals within | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Research Questions: The secondary research questions were developed within the individual research groups and are reflected in the specific investigations. The main modules and their objectives are as follows: Cardiological Imaging: Innovative imaging modalities are used to identify new predictive markers for cardiovascular risk. Multimodal analyses allow for more precise risk assessments, subclinical diagnoses, and personalized prevention measures. Cognitive factors such as risk perception and health literacy are also included. Thromboinflammation and Hemostasis: This module investigates the effects of the LDL-cholesterol-LP(a) constellation and weight reduction on coagulation functions, inflammatory markers, and phospholipid expression. Another focus is the role of the PAR2 receptor in ApoE expression. Physical Activity, Vascular Biology, and Inflammation: The individual metabolic-inflammatory response to stress tests (response to challenge) will be examined in terms of its predictive power for cardiovascular risk. Sleep-Related Breathing Disorders: The identification of biomarkers to predict thrombo-inflammatory risks in obstructive sleep apnea (OSAS). Cognition and Psychology: Psychological factors such as stress, depression, anxiety, and social connectedness are associated with the occurrence of cardiovascular disease (CVD) and can have both direct physiological effects as well as indirect effects through unhealthy lifestyle behaviors like smoking, diet, and physical activity. The complexity, interactions, and biological mechanisms in the early stages of disease development are investigated. Additionally, the study systematically explores how cognitive factors, including risk perception and health literacy, influence the understanding and implementation of preventive recommendations. Thromboinflammation: Characterization of modulating effects on vascular inflammation and thrombosis risk. Vascular and inflammatory impacts of substan | — |
Countries
Germany
Contacts
Public ContactUrsula Rauch-Kröhnert
Charité Universitätsmedizin Berlin / Friede Springer Cardiovascular Prevention Center
Outcome results
None listed