Cardiovascular Risk Factors (e.g., Hypertension)MUSA-BEANCT07207603
Bicocca Epidemiological Assessment of Cardiovascular Risk Factors
An observational study of Cardiovascular Risk Factors (e.g., Hypertension), run by University of Milano Bicocca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors (e.g., Hypertension)
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Individuals living in the area close to University Milano-Bicocca (postcode 20126)
Who cannot join
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observational Cohort Pilot Study on Cardiovascular Prevention in Citizens Living in Milano-Bicocca District
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Cardiovascular risk factor, Italy, Observational Study, Epidemiology, exposome, air pollution, blood pressure, cholesterol, stress
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposome
to define the prevalence of the exposome associated with increased CV risk in an urban population.
The exposome includes the following domains:
- Internal: internal biological processes such as oxidative stress, inflammation, epigenetic changes, metabolism and the internal microbiome.
- General external: social, economic factors, the urban environment and climate factors.
- Specific external: an individual's immediate local environment, including exposure to chemicals, diet, physical activity, tobacco and infections.
Measured: prior index date and at baseline visit
Secondary outcomes (2)
Traditional CV risk factors
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.
Measured: prior index date and at baseline visit
Non traditional risk factors
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.
Measured: prior index date and at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start17 Jun 2024
- Primary completion31 Jan 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk Factors (e.g., Hypertension)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Responsible party
- Sponsor
- Investigators
- Martino F Pengo, Medicine, Principal investigator, University of Milan-Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207603
- Sponsor's protocol ID
- BEA 777
- Acronym
- MUSA-BEA
- Status last verified
- Oct 2025
- First submitted
- 20 Sep 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35346104Chang 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.
PubMed 10964347Cali 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.
PubMed 26379571Schandry 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.
PubMed 7267933Kontiola A. A new electromechanical method for measuring intraocular pressure. Doc Ophthalmol. 1996-1997;93(3):265-76. doi: 10.1007/BF02569066.
PubMed 9550354Curcio 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.
PubMed 22526760Picardi 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.
PubMed 16159733Lorini 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.
PubMed 30968831Steca 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.
PubMed 28919722Poreh 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.
PubMed 26507316Rekers 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.
PubMed 37166580Ragland 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.
PubMed 12146684Morisky 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.
PubMed 3945130Adorni 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.
PubMed 34836035Gnagnarella 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.
PubMed 30077491
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Pilot Study on Cardiovascular Prevention in Citizens Living in Milano-Bicocca District
- ClinicalTrials.gov ID
- NCT07207603
- Acronym / sponsor ID
- MUSA-BEA / BEA 777
- Keywords
- Cardiovascular risk factor, Italy, Observational Study, Epidemiology, exposome, air pollution, blood pressure, cholesterol
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruited individuals | – | Other: No interventionMales or females age > 25 years living in the area close to University Milano-Bicocca (postcode 20126) and able to sign the informed consent. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Individuals living in the area close to University Milano-Bicocca (postcode 20126)
Key exclusion criteria (1 listed)
- Inability to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Recruited individuals |
Primary outcome
Exposome
Time frame: 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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Results publication: PubMed 35346104Luciani 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.
- Results publication: PubMed 10964347Chang 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.
- Results publication: PubMed 26379571Cali 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.
- Results publication: PubMed 7267933Schandry 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.
- Results publication: PubMed 9550354Kontiola A. A new electromechanical method for measuring intraocular pressure. Doc Ophthalmol. 1996-1997;93(3):265-76. doi: 10.1007/BF02569066.
- Results publication: PubMed 22526760Curcio 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.
- Results publication: PubMed 16159733Picardi 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.
- Results publication: PubMed 30968831Lorini 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.
- Results publication: PubMed 28919722Steca 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.
- Results publication: PubMed 26507316Poreh 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.
- Results publication: PubMed 37166580Rekers 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.
- Results publication: PubMed 12146684Ragland 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martino F Pengo, Medicine principal investigator
University of Milan-Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factors (e.g., Hypertension), run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposome (time frame: prior index date and at baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207603, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.