Bicocca Epidemiological Assessment of Cardiovascular Risk Factors

Официальное название

Observational Cohort Pilot Study on Cardiovascular Prevention in Citizens Living in Milano-Bicocca District

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No intervention
  No intervention

Первичные конечные точки

• Exposome [Срок оценки: prior index date and at baseline visit]

Вторичные конечные точки (2)

• Traditional CV risk factors [Срок оценки: prior index date and at baseline visit]
• Non traditional risk factors [Срок оценки: prior index date and at baseline visit]

Критерии участия

Критерии включения

• Individuals living in the area close to University Milano-Bicocca (postcode 20126)

Критерии исключения

• Inability to sign the informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• University of Milan-Bicocca — Milan

Публикации

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Идентификаторы

NCT: NCT07207603 · BEA 777

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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