Bicocca Epidemiological Assessment of Cardiovascular Risk Factors

NCT07207603 | Enrolling By Invitation DMC

• 1 other identifier: BEA 777
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factors (e.g., Hypertension)

Keywords

Cardiovascular risk factor; Italy; Observational Study; Epidemiology; exposome; air pollution; blood pressure; cholesterol; stress

Outcome Measures

Primary Outcomes (1)

• Exposome

  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.

  prior index date and at baseline visit

Secondary Outcomes (2)

• Traditional CV risk factors

  prior index date and at baseline visit

• Non traditional risk factors

  prior index date and at baseline visit

Other Outcomes (1)

• Prevalence of clinical conditions associated with CV risk

  prior index date and at baseline visit

Study Arms (1)

Recruited individuals

Males or females age \> 25 years living in the area close to University Milano-Bicocca (postcode 20126) and able to sign the informed consent.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Recruited individuals

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our target population includes about 15900 residents in the 20126 postcode area with at least 25 years of age. From this population we aim to select a sample of 1000 subjects which will participate in the study.

You may qualify if:

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

You may not qualify if:

• Inability to sign the informed consent

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Istituto Auxologico Italiano: collaborator

Study Sites (1)

University of Milan-Bicocca

Milan, 20126, Italy

Location

Related Publications (28)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Kontiola A. A new electromechanical method for measuring intraocular pressure. Doc Ophthalmol. 1996-1997;93(3):265-76. doi: 10.1007/BF02569066.

  PMID: 9550354 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Steca P, Monzani D, Pierobon A, Avvenuti G, Greco A, Giardini A. Measuring dispositional optimism in patients with chronic heart failure and their healthcare providers: the validity of the Life Orientation Test-Revised. Patient Prefer Adherence. 2017 Sep 6;11:1497-1503. doi: 10.2147/PPA.S139522. eCollection 2017.

  PMID: 28919722 RESULT

• Poreh A, Bezdicek O, Korobkova I, Levin JB, Dines P. The Rey Auditory Verbal Learning Test forced-choice recognition task: Base-rate data and norms. Appl Neuropsychol Adult. 2016;23(3):155-61. doi: 10.1080/23279095.2015.1027343. Epub 2015 Oct 27.

  PMID: 26507316 RESULT

• Rekers S, Finke C. Translating spatial navigation evaluation from experimental to clinical settings: The virtual environments navigation assessment (VIENNA). Behav Res Methods. 2024 Mar;56(3):2033-2048. doi: 10.3758/s13428-023-02134-0. Epub 2023 May 11.

  PMID: 37166580 RESULT

• Ragland JD, Turetsky BI, Gur RC, Gunning-Dixon F, Turner T, Schroeder L, Chan R, Gur RE. Working memory for complex figures: an fMRI comparison of letter and fractal n-back tasks. Neuropsychology. 2002 Jul;16(3):370-9.

  PMID: 12146684 RESULT

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 RESULT

• Adorni R, Zanatta F, D'Addario M, Atella F, Costantino E, Iaderosa C, Petarle G, Steca P. Health-Related Lifestyle Profiles in Healthy Adults: Associations with Sociodemographic Indicators, Dispositional Optimism, and Sense of Coherence. Nutrients. 2021 Oct 25;13(11):3778. doi: 10.3390/nu13113778.

  PMID: 34836035 RESULT

• Gnagnarella P, Draga D, Misotti AM, Sieri S, Spaggiari L, Cassano E, Baldini F, Soldati L, Maisonneuve P. Validation of a short questionnaire to record adherence to the Mediterranean diet: An Italian experience. Nutr Metab Cardiovasc Dis. 2018 Nov;28(11):1140-1147. doi: 10.1016/j.numecd.2018.06.006. Epub 2018 Jun 18.

  PMID: 30077491 RESULT

• Choi M, Mesa-Frias M, Nuesch E, Hargreaves J, Prieto-Merino D, Bowling A, Snith GD, Ebrahim S, Dale C, Casas JP. Social capital, mortality, cardiovascular events and cancer: a systematic review of prospective studies. Int J Epidemiol. 2014 Dec;43(6):1895-920. doi: 10.1093/ije/dyu212.

  PMID: 25369975 RESULT

• Parati G, Stergiou GS, Bilo G, Kollias A, Pengo M, Ochoa JE, Agarwal R, Asayama K, Asmar R, Burnier M, De La Sierra A, Giannattasio C, Gosse P, Head G, Hoshide S, Imai Y, Kario K, Li Y, Manios E, Mant J, McManus RJ, Mengden T, Mihailidou AS, Muntner P, Myers M, Niiranen T, Ntineri A, O'Brien E, Octavio JA, Ohkubo T, Omboni S, Padfield P, Palatini P, Pellegrini D, Postel-Vinay N, Ramirez AJ, Sharman JE, Shennan A, Silva E, Topouchian J, Torlasco C, Wang JG, Weber MA, Whelton PK, White WB, Mancia G; Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension. J Hypertens. 2021 Sep 1;39(9):1742-1767. doi: 10.1097/HJH.0000000000002922.

  PMID: 34269334 RESULT

• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; Authors/Task Force Members:. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018 Oct;36(10):1953-2041. doi: 10.1097/HJH.0000000000001940.

  PMID: 30234752 RESULT

• Ikram MA, Brusselle GGO, Murad SD, van Duijn CM, Franco OH, Goedegebure A, Klaver CCW, Nijsten TEC, Peeters RP, Stricker BH, Tiemeier H, Uitterlinden AG, Vernooij MW, Hofman A. The Rotterdam Study: 2018 update on objectives, design and main results. Eur J Epidemiol. 2017 Sep;32(9):807-850. doi: 10.1007/s10654-017-0321-4. Epub 2017 Oct 24.

  PMID: 29064009 RESULT

• Brodaty H, Pond D, Kemp NM, Luscombe G, Harding L, Berman K, Huppert FA. The GPCOG: a new screening test for dementia designed for general practice. J Am Geriatr Soc. 2002 Mar;50(3):530-4. doi: 10.1046/j.1532-5415.2002.50122.x.

  PMID: 11943052 RESULT

• Galvin JE, Roe CM, Powlishta KK, Coats MA, Muich SJ, Grant E, Miller JP, Storandt M, Morris JC. The AD8: a brief informant interview to detect dementia. Neurology. 2005 Aug 23;65(4):559-64. doi: 10.1212/01.wnl.0000172958.95282.2a.

  PMID: 16116116 RESULT

• Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

  PMID: 10811152 RESULT

• Di Castelnuovo A, Costanzo S, Persichillo M, Olivieri M, de Curtis A, Zito F, Donati MB, de Gaetano G, Iacoviello L; MOLI-SANI Project Investigators. Distribution of short and lifetime risks for cardiovascular disease in Italians. Eur J Prev Cardiol. 2012 Aug;19(4):723-30. doi: 10.1177/1741826711410820. Epub 2011 May 13.

  PMID: 21571772 RESULT

• Farooqi MAM, Gerstein H, Yusuf S, Leong DP. Accumulation of Deficits as a Key Risk Factor for Cardiovascular Morbidity and Mortality: A Pooled Analysis of 154 000 Individuals. J Am Heart Assoc. 2020 Feb 4;9(3):e014686. doi: 10.1161/JAHA.119.014686. Epub 2020 Jan 28.

  PMID: 31986990 RESULT

• Purser JL, Kuchibhatla MN, Fillenbaum GG, Harding T, Peterson ED, Alexander KP. Identifying frailty in hospitalized older adults with significant coronary artery disease. J Am Geriatr Soc. 2006 Nov;54(11):1674-81. doi: 10.1111/j.1532-5415.2006.00914.x.

  PMID: 17087693 RESULT

• Iwasaki A, Pillai PS. Innate immunity to influenza virus infection. Nat Rev Immunol. 2014 May;14(5):315-28. doi: 10.1038/nri3665.

  PMID: 24762827 RESULT

• Munzel T, Sorensen M, Hahad O, Nieuwenhuijsen M, Daiber A. The contribution of the exposome to the burden of cardiovascular disease. Nat Rev Cardiol. 2023 Oct;20(10):651-669. doi: 10.1038/s41569-023-00873-3. Epub 2023 May 10.

  PMID: 37165157 RESULT

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

  PMID: 34458905 RESULT

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloods will be taken by a dedicated Research Nurse and sent for analysis and storage. In detail 5 vacutainers (5 ml each) will be taken for each subject and the following analyses will be performed: glucose level, total cholesterol, HDL, triglycerides, LDLc, ApoB, Lp(a), HbA1c, uric acid, hsPCR. Urine samples will be also collected for urine analysis. Furthermore, two 80 mg stool aliquots will be stored allowing the possibility of evaluating the gut microbiome composition.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martino F Pengo, Medicine

  University of Milan-Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 6, 2025
• Study Start: June 17, 2024
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

IT (1)