Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT07207603
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.
Study:
NCT07207603
Study Brief:
Protocol Section:
NCT07207603