Bicocca Epidemiological Assessment of Cardiovascular Risk Factors
- Conditions
- Cardiovascular Risk Factors (e.g., Hypertension)
- Registration Number
- NCT07207603
- Lead Sponsor
- University of Milano Bicocca
- Brief Summary
The main objective of the study is to characterize the cardiovascular risk profile of the population in the Bicocca district through the evaluation of the exposome and the assessment of traditional and less studied cardiovascular risk factors for cardiovascular disease.
- Detailed Description
STUDY DURATION AND ENROLMENT
The study duration is 3 years. The study will be conducted at University of Milano-Bicocca in an ad-hoc site dedicated to the project.
STUDY POPULATION
Inclusion Criteria: Males or females age \> 25 years living in the area close to University Milano-Bicocca (postcode 20126) Exclusion Criteria: Inability to sign the informed consent
STUDY PROCEDURES During the screening visit the Investigators will double check that the subject can be included according to the aforementioned inclusion and exclusion criteria.
Informed Consent will be signed by both Investigator and Subject enrolled.
OBSERVATIONAL PERIOD
If the screening visit is successful (if the subjects meet the inclusion criteria and does not meet the exclusion criteria) the main visit will be scheduled or can be performed at the same time of the screening visit if feasible. If possible, all study procedures will be performed on the same day. If not, the study procedures will be scheduled and the subject will be invited to come in the following days. If possible, self-report questionnaires not requiring any supervision will be administered digitally through an ad hoc web platform (i.e., Qualtrics) in order to save time and reduce the participant's time spent at the research facility.
STUDY EVALUATIONS AND MEASUREMENTS
* Demographic and clinical characteristics;
* Medical history;
* Current treatment;
* Physiscal examination;
* Vital signs;
* Laboratory evaluations;
* Questionaires (lifestyle profiles; cognitive functions; psychological dispositions; health-related psychological dispositions; perceived health and wellbeing; stress);
* Frailty assessment (in elderly participants only)
* Lung Function test;
* ECG/Ambulatory blood pressure measurement/heandgrip test/PWA and PWV assessment/optical cohoerence tomography angiography and non-mydriatic fundus retinography/Air pollutant assessment
STATISTICAL ANALYSIS Data will be summarised by standard descriptive summaries (e.g. means and standard deviations for continuous variables such as age and percentages for categorical variables such as gender). Appropriate statistical methods will be adopted to assess the association between cardiovascular factors and global cardiovascular risk profile.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- Individuals living in the area close to University Milano-Bicocca (postcode 20126)
- Inability to sign the informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exposome prior index date and at baseline visit to define the prevalence of the exposome associated with increased CV risk in an urban population.
The exposome includes the following domains:
1. Internal: internal biological processes such as oxidative stress, inflammation, epigenetic changes, metabolism and the internal microbiome.
2. General external: social, economic factors, the urban environment and climate factors.
3. Specific external: an individual's immediate local environment, including exposure to chemicals, diet, physical activity, tobacco and infections.
- Secondary Outcome Measures
Name Time Method Traditional CV risk factors prior index date and at baseline visit the prevalence of the known CV risk factors (e.g., high blood pressure, diabetes, smoking status, dyslipidaemia) will be evaluated according to current Guidelines for Cardiovascular Prevention.
In addition to this the following known risk factors will be determined as follows
* The non-adequacy of physical activity will be established based on the IPAQ total score. A score below 3000 MET-minute/week is indicative of an inactive lifestyle. Also, the categorical score that identifies "inactive," "minimally active," and "HEPA active" will be used to classify participants;
* The non-adequacy of eating habits will be established based on the MD score of the QueMD scale. A score below 5 suggests good adherence to the Mediterranean diet;
* Alcohol consumption will be evaluated through the individual scores on the AUDIT-C. A score equal to or greater than 5 for males and equal to or greater than 4 for females indicates a possible risky consumption of alcohol.Non traditional risk factors prior index date and at baseline visit prevalence of new/less studied risk modifiers (including psychological profiles associated with unhealthy lifestyle and misperception of CV risk) in an urban population.
Specifically:
* the prevalence of psychosocial stress will be determined through the evaluation of individual scores on the PSS.
* the presence of anxiety symptoms will be determined by evaluating individual scores on the GAD-7;
* the presence of depressive symptoms will be evaluated through the individual scores on the PHQ-9;
* the prevalence of frailty in the elderly participants will be determined according to the Fried's frailty phenotype;
* the prevalence of short (\<6 hours of sleep) and long sleepers (\>8 hours of sleep) will be defined by the Pittsburgh sleep quality index;
* the prevalence of low socioeconomic status will be determined as well as work stress defined by job strain (i.e. the combination of high demands and low control at work) and effort-reward imbalance.
Trial Locations
- Locations (1)
University of Milan-Bicocca
🇮🇹Milan, Italy
University of Milan-Bicocca🇮🇹Milan, Italy