Progetto CUORE. Epidemiologia E Prevenzione Delle Malattie Cardio-Cerebrovascolari

Objectives

The CUORE Project, including the Cardiovascular Epidemiological Observatory and Health Examination Survey, is a national cardiovascular surveillance initiative designed to describe the prevalence of cardiovascular and cerebrovascular diseases, risk factors, risk conditions and treatment indicators in representative Italian population samples aged 35–79 years.[1][2][3]It seeks to generate comparable evidence for prevention and policy evaluation, assess temporal changes since the 1998–2002 survey, and contribute standardised Italian data to the European Health Examination Survey.[4][2][5]

• Measure the distribution and average levels of cardiovascular risk factors, including hypertension, dyslipidaemia, overweight and obesity, diabetes, smoking, diet, physical activity and lifestyle behaviours.[6][2][7]
• Estimate the prevalence of serious ischaemic heart disease, stroke and other chronic conditions, alongside prior cardiovascular events, high-risk conditions and treatment indicators.[2][3][7]
• Identify population groups and geographical areas requiring preventive, diagnostic, therapeutic and care interventions.[6][2][7]
• Monitor trends in cardiovascular disease, risk-factor patterns and the effects of health-promotion initiatives, including salt-reduction measures implemented through the Guadagnare Salute programme.[2][8][9]
• Support prevention of cardiovascular and cerebrovascular disease, which is identified as a leading cause of mortality, hospital admission, disability and later-life cognitive impairment.[10][3][7]
• Extend surveillance to chronic-disease determinants, renal health and nutritional exposures through the Cardiovascular Risk in Renal Patients of the Italian Health Examination Survey study and the MINISAL-GIRCSI study of dietary sodium, potassium and iodine.[6][8][11]
• Maintain an active cardiovascular disease registry and follow participants over time for all-cause and cause-specific mortality and fatal and non-fatal coronary and cerebrovascular events.[6][12][9]

Implementation

The project uses repeated, population-based health examinations rather than relying solely on self-reported questionnaires.[5]It combines stratified random sampling, direct clinical examination, questionnaires, laboratory investigations, biological-sample banking and longitudinal follow-up, using standardised procedures, equipment, diagnostic criteria and quality controls to support national and European comparability.[1][12][11]The Italian National Institute of Health, or Istituto Superiore di Sanità (ISS), coordinates training, standardisation, technical support, data processing and analysis, in collaboration with the National Association of Hospital Cardiologists, local health authorities, hospitals, universities and specialist laboratories.[13][14][3]

• Recruit a national sample of 9,020 people, comprising 4,510 men and 4,510 women aged 35–79 years, using approximately 220 participants for every 1.5 million inhabitants and age- and sex-specific quotas.[12][15][16]
• Select participants randomly from municipal population registers, invite replacements when selected people refuse or cannot be contacted, document refusals and calculate participation rates.[16][17]
• Operate through 20 local units, normally one per region, while limiting the number of centres to reduce variability, strengthen quality control and reduce operational complexity.[18][19][20]
• Train field staff and use an operations manual covering recruitment, consent, questionnaires, clinical assessment, sample handling, laboratory processing, data entry and disease classification.[21][22][19]
• Collect demographic, socioeconomic, family-history, health-service-use, lifestyle, dietary and medical-history information through standardised electronic and self-administered questionnaires.[22][23][24]
• Measure blood pressure, heart rate, anthropometry, electrocardiography, spirometry, bone density and exhaled carbon monoxide, and collect fasting blood and 24-hour urine samples.[18][25][24]
• Analyse blood samples for lipids, glucose, renal markers and related measures through collaborating laboratories in Campobasso, Naples and Pisa, including urine analysis for creatinine, albumin, sodium, potassium and iodine.[26][27][28]
• Store serum, plasma, buffy coat, packed red cells and urine in the ISS biological sample bank, with samples retained for at least 30 years to enable future research on risk-factor and disease associations.[12][11][29]
• Apply ethics, consent and privacy safeguards, including ISS Ethics Committee approval, voluntary participation, the right to withdraw, controlled access to sensitive data and publication of results only in aggregated form.[8][30][31][29]
• Conduct field quality checks at the beginning and end of local operations, reviewing methodological standardisation, participation, refusals, documentation and operational difficulties.[13]Apply measurement-specific controls for blood pressure, anthropometry, electrocardiography, densitometry, questionnaires and laboratory sample processing.[22][32][27]
• Analyse results by age, sex, region and macro-area, using European-standard age adjustment where appropriate, and publish regional, macro-area and national findings through the CUORE Project website.[33][7][5]
• Provide participants with examination and laboratory results, cardiovascular-risk information where applicable, and advice on healthy eating, physical activity, smoking avoidance and reduced salt consumption for discussion with their general practitioner.[27][11][34]
• Finance the project through the Ministry of Health’s Centre for Disease Control within the Guadagnare Salute programme, while additional funding supports renal-risk investigations.[8][3][9]A budget of 10,000 euros per 220 people examined is specified for local screening personnel, laboratory staff, selected tests and electrocardiogram interpretation.[35]

Monitoring & Evaluation

The CUORE Project and Cardiovascular Epidemiological Observatory use repeated, population-based health examination surveys and an active cardiovascular disease registry to measure cardiovascular and cerebrovascular disease burden, risk factors, high-risk conditions and treatment indicators in Italy.[6][24]Survey findings are intended to support prevention-policy assessment, comparisons with the 1998–2002 Observatory survey and contribution to the European Health Examination Survey.[2][5]

• Monitor prevalence of serious ischaemic heart disease, stroke, other chronic conditions, hypertension, dyslipidaemia, overweight, obesity, diabetes, smoking and lifestyle-related risk factors in representative samples of people aged 35–79 years.[2]
• Measure anthropometric, physiological, clinical and biochemical variables, alongside information on diet, physical activity, tobacco and alcohol use, health-service access, functional capacity and nutritional status.[6][24]
• Follow enrolled participants for all-cause and cause-specific mortality and fatal and non-fatal coronary and cerebrovascular events, using mortality data, hospital-discharge diagnoses, clinical records and other sources to identify and validate outcomes.[12][11][29]
• Assess temporal trends by comparing standardised, age-adjusted results by sex, region, macro-area and Italy overall, while taking regional sample size into account when interpreting estimates.[33][8]
• Monitor dietary sodium, potassium and iodine intake, including evaluation of the policy to reduce salt in bread and bakery products.[8]
• Use chronic kidney disease investigations through the Cardiovascular Risk in Renal Patients of the Italian Health Examination Survey project and sodium, potassium and iodine investigations through MINISAL-GIRCSI as linked analytical components.[8]

Data quality is supported by standardised procedures, staff training, central coordination by the Istituto Superiore di Sanità, internationally aligned quality controls, pilot testing, centralised laboratory analysis and electronic data collection.[12][22][14]Routine operational checks cover completion of screening stages and questionnaires, measurement consistency, equipment functionality, biological-sample identification and laboratory-processing controls.[19][36][37]

• Track participation, refusals, reasons for replacement, operational difficulties and completeness of documentation during fieldwork.[13][17]
• Assess blood-pressure data quality through completeness of three systolic and three diastolic readings, repeated-value patterns and terminal-digit distributions; assess weight and height data for completeness and digit preference.[27]
• Conduct quality-control checks for bone densitometry before screening and weekly during fieldwork, retaining printed results.[38]
• Review electrocardiograms centrally using the Minnesota Code and use predefined combinations of questionnaire responses, clinical documentation, hospital records and coded electrocardiograms to classify cardiovascular outcomes.[39][32]
• Maintain electronic records, submit local data to the Istituto Superiore di Sanità for processing and statistical analysis, and preserve biological samples to enable future research and event-based analyses.[15][14][11]

Results are planned for publication through the CUORE Project website at regional, macro-area and national levels, and participants receive their examination and laboratory findings.[6][27]The extracts identify the Istituto Superiore di Sanità as responsible for data ownership, preservation, processing and analysis, with ethics oversight and data-protection safeguards supporting accountability.[15][8][31]A comprehensive formal performance-indicator framework, fixed reporting timetable and explicit mechanism for accountability for action on findings are not specified.[24][7][5]

Costing & Financing

Project financing is provided by the Italian Ministry of Health through its Centre for Disease Control and the CUORE programme is included within the Guadagnare Salute programme.[8][9]Additional funding for Cardiovascular Risk in Renal Patients of the Italian Health Examination Survey investigations is managed by the Association of Hospital Cardiologists and the Heart Care Foundation.[8][35]

• Allocate a budget of 10,000 euros per 220 people examined under the Association of Hospital Cardiologists and Istituto Superiore di Sanità agreement; covered inputs include local screening staff, laboratory staff, total and high-density lipoprotein cholesterol testing, glucose testing, full blood counts and electrocardiogram interpretation.[35]
• Provide central equipment, training, standardisation, quality control, data analysis, biological-sample storage and laboratory support through national and collaborating institutions.[13][19]
• Require local health authorities and participating centres to support premises, staff, local laboratory capacity, equipment, sample storage, biological-material transfer and waste disposal.[40][36]
• Recognise that the earlier multi-centre design was operationally complex and relatively costly because standardisation and quality control were required; the revised design sought to reduce costs by limiting local units and centralising measurements and laboratory determinations.[41]
• Note that fieldwork may face limited funding because screening must be integrated with routine activities.[40]

The supplied material identifies historical project and research funding streams, but does not provide a consolidated project budget, total expenditure, detailed funding allocations, quantified funding gap, costing methodology or broader economic assumptions.[35]