Bicocca Epidemiological Assessment of Cardiovascular Risk Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular Risk Factors (e.g., Hypertension). Basic parameters: from 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Cohort Pilot Study on Cardiovascular Prevention in Citizens Living in Milano-Bicocca District
Overview
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.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Exposome [Time frame: prior index date and at baseline visit]
Secondary outcome measures (2)
- Traditional CV risk factors [Time frame: prior index date and at baseline visit]
- Non traditional risk factors [Time frame: prior index date and at baseline visit]
Eligibility criteria
Inclusion criteria
- Individuals living in the area close to University Milano-Bicocca (postcode 20126)
Exclusion criteria
- Inability to sign the informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Milan-Bicocca — Milan
Publications
- Luciani M, De Maria M, Page SD, Barbaranelli C, Ausili D, Riegel B. Measuring self-care in the general adult population: development and psychometric testing of the Self-Care Inventory. BMC Public Health. 2022 Mar 28;22(1):598. doi: 10.1186/s12889-022-12913-7. PMID 35346104
- Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y. PMID 10964347
- Cali G, Ambrosini E, Picconi L, Mehling WE, Committeri G. Investigating the relationship between interoceptive accuracy, interoceptive awareness, and emotional susceptibility. Front Psychol. 2015 Aug 24;6:1202. doi: 10.3389/fpsyg.2015.01202. eCollection 2015. PMID 26379571
- Schandry R. Heart beat perception and emotional experience. Psychophysiology. 1981 Jul;18(4):483-8. doi: 10.1111/j.1469-8986.1981.tb02486.x. No abstract available. PMID 7267933
- Kontiola A. A new electromechanical method for measuring intraocular pressure. Doc Ophthalmol. 1996-1997;93(3):265-76. doi: 10.1007/BF02569066. PMID 9550354
- Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13. PMID 22526760
- Picardi A, Adler DA, Abeni D, Chang H, Pasquini P, Rogers WH, Bungay KM. Screening for depressive disorders in patients with skin diseases: a comparison of three screeners. Acta Derm Venereol. 2005;85(5):414-9. doi: 10.1080/00015550510034966. PMID 16159733
- Lorini C, Lastrucci V, Mantwill S, Vettori V, Bonaccorsi G; Florence Health Literacy Research Group. Measuring health literacy in Italy: a validation study of the HLS-EU-Q16 and of the HLS-EU-Q6 in Italian language, conducted in Florence and its surroundings. Ann Ist Super Sanita. 2019 Jan-Mar;55(1):10-18. doi: 10.4415/ANN_19_01_04. PMID 30968831
Identifiers
NCT: NCT07207603 · BEA 777