Progetto CUORE. Epidemiologia E Prevenzione Delle Malattie Cardio-Cerebrovascolari

Objectives

The CUORE Project and Cardiovascular Epidemiological Observatory/Health Examination Survey establish a national population-based surveillance framework for cardiovascular and cerebrovascular health in Italy. Its purpose is to estimate the prevalence of severe ischaemic heart disease, stroke and other chronic conditions; measure cardiovascular risk factors, high-risk conditions and treatment indicators; and identify priorities for prevention, diagnosis, treatment and care.[1][2][3]The survey also contributes standardised population health data to the European Health Examination Survey.[4][5]

• Measure the distribution and average levels of cardiovascular risk factors, including hypertension, dyslipidaemia, obesity, diabetes, lifestyle habits and dietary determinants, in representative adults aged 35–79 years.[1][6][3]
• Estimate disease prevalence, attack rates and case fatality for severe ischaemic heart disease and stroke through repeated population surveys and an active cardiovascular disease register.[1][3]
• Assess changes over time in risk factors, high-risk conditions and major cardiovascular and cerebrovascular diseases, including comparison with the 1998–2002 Observatory survey.[2][7]
• Identify people at elevated cardiovascular risk and those with previous cardiovascular or cerebrovascular events, supporting appropriate prevention and clinical follow-up.[8][9]
• Support prevention by addressing modifiable risks, including smoking, unhealthy diet, excess salt intake, physical inactivity and unhealthy weight, to reduce or delay cardiovascular events.[6][3][10]
• Integrate research on chronic kidney disease and cardiovascular risk through the Cardiovascular Risk in Renal Patients of the Italian Health Examination Survey study, and assess dietary sodium, potassium and iodine intake through the MINISAL-GIRCSI study.[1][11][12]
• Generate national, macro-area and regional evidence on health behaviours, chronic disease, functional capacity, nutritional status and access to health and social care.[1][5]

Implementation

Implementation uses a standardised, geographically distributed health examination survey, coordinated by the Italian National Institute of Health through its National Centre of Epidemiology, Surveillance and Health Promotion, in collaboration with the National Association of Hospital Cardiologists and participating local health services.[4][6][13]The model combines random population sampling, local screening delivery, centralised laboratory analysis, long-term biological-sample banking, longitudinal follow-up and quality-controlled data analysis.[14][13][12]

• Recruit a random, age- and sex-stratified sample of 9,020 adults aged 35–79 years, comprising 4,510 men and 4,510 women, with approximately 220 participants per 1.5 million inhabitants.[14][15][16]
• Operate through one local unit per region, or at most two in more populous regions, using municipal population registers to select and invite residents.[17][16][5]
• Engage local health authorities, hospitals, prevention districts, general practitioners and municipal registrars to provide premises, staff, participant recruitment, laboratory support, storage facilities and waste disposal.[15][18][19]
• Train screening personnel and apply standardised protocols, international recommendations and field quality controls for all examinations, instruments and data-collection procedures.[14][20][16]
• Obtain informed voluntary consent for participation, research use of data, follow-up, registry searches and future analyses of stored biological material; permit withdrawal at any time.[21][8][22]
• Conduct standardised examinations including questionnaires, blood pressure and heart-rate measurement, anthropometry, fasting blood sampling, electrocardiography, spirometry, bone densitometry, carbon-monoxide assessment, dietary assessment and 24-hour urine collection.[17][23][13]
• Analyse biological samples through central laboratories in Campobasso, Naples and Pisa, while retaining serum, plasma, buffy coat, packed red cells and urine in the National Institute of Health biological sample bank for at least 30 years.[24][13]
• Process and store data under the responsibility of the Italian National Institute of Health, with local units transmitting electronic records, participant lists, refusals, replacements and examination materials for central analysis.[15][16][24]
• Follow enrolled participants for all-cause and cause-specific mortality and fatal and non-fatal coronary and cerebrovascular events, using validated mortality, clinical and hospital-discharge information.[14][12][22]
• Report results for Italy, macro-areas and regions, publish findings through the CUORE Project website, and return individual examination results and lifestyle advice to participants for discussion with their general practitioner.[7][3][13]
• Protect personal and sensitive data by restricting access to authorised personnel, separating identifying information from socio-health data, and enabling participants to request correction, anonymisation, erasure or destruction of stored samples.[25][26]
• Finance the project through the Ministry of Health’s Centre for Disease Control, with additional historical support through national health service funding, Ministry and National Institute of Health agreements, intramural research and associated project arrangements.[27][24][12]A budget of 10,000 euro per 220 people examined is specified for the ANMCO/ISS agreement, covering local screening and laboratory personnel, selected laboratory tests and electrocardiogram interpretation for participant feedback.[27]

Monitoring & Evaluation

The CUORE Project uses population-based cardiovascular surveillance to measure disease burden, risk factors, risk conditions, treatment indicators and temporal trends in adults aged 35–79 years. It combines periodic health examination surveys, an active cardiovascular disease register, longitudinal follow-up and standardised clinical, laboratory and questionnaire data collection.[1][3][12]

• Monitor prevalence, attack rates and case fatality for severe ischaemic heart disease and stroke, alongside average risk-factor levels, high-risk conditions and treatment indicators.[1][3]
• Follow enrolled participants for all-cause and cause-specific mortality and for fatal and non-fatal coronary and cerebrovascular events, using validated linkages to mortality records, hospital-discharge data, population registers and clinical documentation.[14][12][22]
• Measure anthropometric, physiological, clinical and biochemical indicators, including blood pressure, lipids, glucose, electrocardiograms, spirometry, bone density, renal markers and 24-hour urinary sodium, potassium and iodine.[2][28][24]
• Assess participation using the number attending divided by eligible invited people, while recording refusals, substitutions and reasons for replacement.[29]
• Apply standardised sampling, diagnostic criteria, measurement procedures, operations manuals, staff training and field quality controls to support comparability between regions, macro-areas and previous survey rounds.[4][20][16]
• Conduct quality checks on blood-pressure completeness, identical readings and terminal-digit distributions, and on missing or rounded height and weight measurements.[30]
• Maintain electronic data-quality checks, direct data entry, regular backups, central statistical analysis and transfer of centre-level records to the Italian National Institute of Health.[15][31][32]
• Store biological samples and screening data for long-term research, with samples retained for at least 30 years to enable analysis of associations between risk factors and later cardio-cerebrovascular events.[13][22]
• Publish results for Italy, macro-areas and regions on the CUORE Project website after regional analyses, while considering regional sample size in interpretation.[7][33]
• Provide participants with examination findings, including laboratory and instrumental results, for review with their general practitioner and offer lifestyle advice.[30][13]
• Protect personal data through informed consent, restricted access, separation of identifying and health information, and participants’ rights to access, correct, object to processing or request sample destruction.[25][26]

Accountability is principally assigned through the Italian National Institute of Health’s responsibilities for training, standardisation, quality control, data ownership, storage, analysis and reporting, alongside ethics-committee approval and local-centre responsibilities for recruitment and delivery.[11][33][18]The material does not specify a consolidated numerical performance-target framework, routine reporting timetable or wider formal accountability mechanism beyond these institutional, ethical and operational arrangements.[33][34][12]

Costing & Financing

Financing is provided through Ministry of Health and Italian National Institute of Health research arrangements, principally the Ministry of Health’s Centre for Disease Control, with additional support linked to the CUORE Project, the National Health Service, MINISAL-GIRCSI, CARHES and agreements involving the National Association of Hospital Cardiologists.[4][27][6][12]

• Allocate a stated budget of 10,000 euro for every 220 people examined under the ANMCO/ISS agreement, covering local screening and laboratory personnel, selected laboratory tests and electrocardiogram reading for participant feedback.[27]
• Use one local unit per region, or at most two in populous regions, and centralise laboratory determinations to reduce the complexity and relative cost of standardisation and quality control.[35]
• Draw on local health-authority in-kind contributions, including screening premises, nursing, administrative, medical and laboratory staff, equipment, sample storage, waste disposal and laboratory testing where required.[18][19]
• Manage financial support to local centres through the National Association of Hospital Cardiologists in collaboration with research directors, while recognising that limited funds may complicate screening organisation.[18]
• Provide participation free of charge for study participants.[8]

A one-percent allocation from the National Health Service Fund funded the “Cuore: epidemiologia e prevenzione delle malattie ischemiche del cuore” project during 1998–2002.[27]Apart from the stated per-220-person budget, the available material does not specify a total programme budget, detailed expenditure plan, funding-gap value, financing timetable, resource-mobilisation target or economic assumptions.[11][27][18]