Clinical trial NCT05339841: Italian Digital Primary Cardiovascular Prevention Study
Official title: Digital Strategies in Primary Cardiovascular Prevention in the Italian Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Population
Keywords: CV primary prevention
CV risk factors
Hypertension
Diabetes
Hypercholesterolemia
Lifestyle behaviours
Digital Health
mHealth
Mobile app
Health empowerment
Primary care
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
name: Humanitas Hospital, Italy
name: Istituto Di Ricerche Farmacologiche Mario Negri
name: IRCCS Multimedica
name: Neuromed IRCCS
name: IRCCS Policlinico S. Donato
name: Istituti Clinici Scientifici Maugeri SpA
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Ospedale Policlinico San Martino
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: IRCCS San Raffaele Roma
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2022-04-21
Enrollment: 27520
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in two parallel groups:" intervention group" and "usual care". In the setting of general medicine, the procedure randomises the general practitioners (GPs) assuring that in each recruiting centre the number of GPs assigned to the control group (usual care) is balanced with that assigned to the intervention group. In the setting of community pharmacies, the procedure randomises the pharmacies assuring that in each geographic area the number of pharmacies assigned to the control group and is balanced with that assigned to the intervention group. In the setting of IRCCS the procedure directly randomises the patients.
Primary purpose: PREVENTION

Brief summary: The CV-PREVITAL study is a randomised clinical trial (RCT) controlled versus usual-care designed to compare the effectiveness of a mobile health (mHealth) intervention with that of usual care in reducing specific cardiovascular (CV) risk factors (in the short term) and the occurrence of vascular events (in the long term). Promoted by the Italian Network of Cardiology (ICN, a cardiovascular research network promoted by the Italian Ministry of Health), in collaboration with the Consorzio Sanità (Co.S., an Italian consortium of general practitioners), CV-PREVITAL aims to develop an innovative model of cardiovascular primary prevention and to validate it in a very large sample of subjects and in 'real life' conditions.

Detailed description: CV-PREVITAL is an RCT investigating whether an mHealth application (App) provided on top of usual care, can improve lifestyle habits and CV risk factor control in the short-term, and the incidence of major CV events in the long- term. Participants undergo two clinical visits, the first at baseline and the second after 12 months. During these visits, total cholesterol, HDL, LDL, triglyceride, HbA1c, blood pressure, heart rate, BMI and waist circumference are measured. In addition, using questionnaires provided digitally, participants self-report data on the following topics: adherence to the Mediterranean diet, salt intake, alcohol consumption, physical activity, current and previous smoking history, psychosocial profile, and sleep quality. Demographic information, including education, socio-economic status and ethnic origin are also obtained at baseline. Subjects in the intervention group also receive the credentials to download the App, which contains educational information on cardiovascular risk factors, diet, physical activity, lifestyle and psycho-behavioral aspects. Using ad hoc designed algorithms, the App delivers personalized prevention programs based on periodic messages providing advice, motivational reminders and support to improve lifestyle and risk factor control. When at baseline high levels of blood pressure, blood glucose or cholesterol are detected, the App support the participant in self-monitoring the clinical changes of such variables during the follow up. The efficacy of the intervention is evaluated at the12th month using a cardiovascular risk score developed ad hoc in an Italian population (Modified Moli-Sani Score). The ability of the intervention to maintain its effect over time and its effectiveness in improving clinical outcomes are assessed at the 7th year of follow-up. The cost-effectiveness of the intervention is also evaluated at the 7th year.

The study envisages the recruitment of 82,800 participants (aged ≥45y) nationwide. Of these, 50,000 are selected among those who daily access the GPs ambulatories associated to the Co.S. consortium. In order to assess whether the scheduled mHealth intervention can be effective also in settings different from the primary care, several specific cohorts in primary prevention are also enrolled by specialized units belonging to Scientific Institutes for Research, Hospitalization and Health Care (Italian acronym IRCCS). These cohorts include 32,800 subjects in total. Specifically, the UO-1 (IRCCS Cardiologico Monzino in Milan) enrolls 5,000 participants selected among citizens attending to community pharmacies; the UO-2 (IRCCS Auxologico in Milan) enrolls 5,000 subjects, 1,500 of which belonging to the Centre for Sleep Medicine; the UO-3 (IRCCS Humanitas in Milan) enrolls 2,000 subjects attending the institution; the UO-4 (IRCCS Mario Negri in Milan) does not recruit any subject but provides scientific and organizational support for the enrolment carried out by Co.S.; the UO-5 (IRCCS MultiMedica in Milan) enrolls 1,000 subjects with diabetes and 2,000 subjects from the general population; the UO-6 (IRCCS Neuromed in Pozzilli) enrols 10,000 subjects from the Neuromed clinical research centres; the UO-7 (IRCCS San Donato in Milan) enrolls 1,000 subjects selected among its own employees; the UO-8 (IRCCS Maugeri in Pavia) enrolls 1,000 subjects selected among its own employees; the UO-9 (IRCCS ISMETT, Mediterranean Institute for Transplantation and Advanced Specialized Therapies, in Palermo) enrolls 150 subjects who undergoes a physical activity program; the UO-10 (IRCCS San Martino in Genoa) enrolls 2,000 male subjects from the Municipality of Genoa; the UO-11 (IRCCS Ca' Granda of Milan) enrolls 2,000 blood donors afferent to its own Department of Transfusion Medicine and Hematology (DMTE); the UO-12 (IRCCS Gemelli in Rome) enrolls 1,000 subjects attending to the outpatient clinics of the Non-Invasive Cardiology Diagnostic Unit, of the Centre for Hypertension, and of the Centre for Endocrine and Metabolic Diseases; the UO-13 (IRCCS San Matteo in Pavia) enrolls 500 subjects selected among asymptomatic relatives of patients attending to the Policlinico San Matteo for cardiology reasons; the UO-14 (IRCCS San Raffaele in Rome) enrolls 150 subjects selected among its own employees.

Baseline data of the 82,800 participants and 1- and 7-years outcomes are also used to develop and validate a new algorithm for cardiovascular risk estimation. The new algorithm is developed by identifying among alcohol intake (as assessed by PREDIMED questionnaire), salt intake (as assessed by MiniSal questionnaire), perceived stress (as assessed by perceived stress scale (PSS), anxiety and depression (as assessed by Patient Health Questionnaire 4; PHQ 4), Locus of control (as assessed by Multidimensional Health Locus of Control scale, MHLCS), General Self Efficacy (as assessed by General Self Efficacy Scale; GSE), Risk propensity (as assessed by Risk Propensity Scale; RPS), and sleep quality (as assessed by Pittsburgh Sleep Quality Index) those variables that significantly improve the predictive power of the modified Moli-Sani algorithm.

The CV-PREVITAL trial also envisages a series of ancillary studies that are conducted by the various IRCCSs on the subjects already participating in the main study. Each ancillary study has its own protocol and aims, and foresees the evaluation of the role of further biomarkers relevant in the assessment of cardiovascular risk. The sub-study aims, outcomes information and time frame are described below. Baseline data of many ancillary studies are used to identify conventional and emerging determinants of specific cardiometabolic diseases. Specifically: a) the IRCCS Monzino analyses with multivariable approaches determinants and factors predisposing to diabetes status as assessed by Framingham diabetes score; b) the IRCCS Auxologico will apply additional elements for risk stratification including biomarkers high sensitive C-reactive protein (hs-CRP), Troponin I, N-terminal pro-brain natriuretic peptide (NT-proBNP), as well as 24 h ABPM (Ambulatory Blood Pressure Monitoring) derived variables; c) the IRCCS Humanitas analyses the frequency of genetic polymorphisms related to severe coronary calcification of its own cohort to identify genetic determinants of severe coronary calcification; d) the IRCCS MultiMedica analyses with multivariable approaches anthropometric (e.g. weight, height, BMI), biochemical data (e.g. lipid profile) and specific genetic disorders (e.g. presence of causative mutations in known genes involved in dyslipidemia) to identify determinants predisposing to dyslipidemia, hypertension and diabetes; e) the IRCCS Neuromed analyses with multivariable approaches determinants of dietary changes in the CV-PREVITAL Neuromed sub-study cohort; f) the Istituti Clinici Scientifici Maugeri IRCCS analyses baseline data of its own cohort with multivariable approaches to identify determinants of organ damage such as coronary silent ischemia, ankle brachial index, coronary calcium score and carotid ultrasound as well as Genetic and epigenetic (DNA and RNA) and other chemical determinants and factors predisposing to atherosclerotic diseases; g) the IRCCS Ca' Granda performs a 7 years validation of new monogenic and polygenic cardiovascular risk scores in its own primary prevention cohort. To this aim the study cohort is genotyped with GWAS and Whole Exome Sequencing (WES) for genetic factors influencing intracellular lipid handling (PNPLA3 I148M, TM6SF2 E167K, GCKR P446L, MBOAT7). Epigenetic variables indicated in the literature as early predictors of cardiovascular injury and cardiovascular events are also investigated. In addition to the characterization of genetic variants in known associated genes, the genomic characterization will allow the validation of candidate risk variants in genes reported to influence cardiovascular damage, the identification of potentially new candidate variants, and the calculation of polygenic cardiovascular risk scores and of their possible application to disease risk stratification in the Italian population; h) the IRCCS San Matteo develops new monogenic and polygenic scores and validates existing scores for the risk assessment of developing diabetes, hypertension and hypercholesterolemia.

Beyond the specific aims of the single sub-studies, a relevant goal common to all sub-studies is the collection of biological samples for the multisite biobank of the ICN.

The full list of approving body and approval number/ID of CV-PREVITAL studies is reported below.

Parent study: Approval Number: R1256/20-CCM 1319; Board Name: Comitato Etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino.

Ancillary studies of Monzino: Approval Number: R1579/21-CCM 1677 and R1617/22-CCM 1723; Board Name: Comitato Etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino.

Ancillary study of Istituto Auxologico Italiano: Approval Number: 2022_03_08_06; Board Name: Comitato Etico dell'IRCCS Istituto Auxologico Italiano.

Ancillary study of Humanitas: Approval Number: 2860; Board Name: Comitato Etico Indipendente dell'Istituto Clinico Humanitas.

Ancillary study of Multimedica: Approval Number: MM: 472.2021; Board Name: Comitato Etico IRCCS Multimedica - Sezione del Comitato Etico Centrale IRCCS Lombardia.

Ancillary study of Neuromed: Approval: Session of 28/09/2020; Board Name: Comitato Etico dell'Istituto Neurologico Mediterraneo Neuromed.

Ancillary study of San Donato: Approval Number: 197/INT/2021; Board Name: Comitato Etico IRCCS Ospedale San Raffaele.

Ancillary study of Maugeri: Approval Number: 2575 CE; Board Name: Comitato Etico degli Istituti Clinici Scientifici Maugeri.

Ancillary study of ISMETT: Approval Number: IRRB/16/22; Board Name: Comitato Etico IRCCS Sicilia.

Ancillary study of San Martino: Approval Number: 173/2021; Board Name: Comitato Etico Regionale della Liguria.

Ancillary study of Ca' Granda: Approval Number: 887_2020; Board Name: Comitato Etico Milano Area 2.

Ancillary study of Gemelli: Approval Number: 3614; Board Name: Comitato Etico della Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore.

Ancillary study of San Matteo: Approval Number: 2022-3.11/91 and 2022-3.11/493; Board Name: Comitato Etico Pavia.

Ancillary studiy of San Raffaele Roma: Approval Number: 21/21; Board Name: Comitato Etico IRCCS San Raffale Roma.

Update on Study Progress and Power Analysis: In its original design, the CV-PREVITAL study aimed to enrol approximately 80,000 subjects aged ≥45 years with no previous cardiovascular events. These participants were intended to be recruited from general practice clinics, pharmacies, or clinics of Scientific Institutes for Research, Hospitalization and Health Care (IRCCS). However, due to the challenges posed by the COVID-19 pandemic, which has fully engaged all parties involved in the study (primarily general practitioners, pharmacists, and IRCCS physicians), the planned activities of the study have been significantly delayed, especially in terms of participant enrollment. Despite these challenges, the study successfully recruited around 28,000 subjects, which is expected to be a sufficient number for evaluating the short-term primary endpoint. Specifically, to assess the short-term primary endpoint, a sample size of N=7895 per treatment arm is required, assuming a significance level of 0.05 and a power of 90%. Therefore, if the target of 16,000 subjects with completed follow-up is achieved, the study will have adequate power to reach the short-term primary endpoint. The estimation of the statistical power for the long-term endpoint will be carried out at the conclusion of the 7-year follow-up period when data regarding the actual dropout rate become available.

Eligibility criteria: Inclusion Criteria:

* Subjects aged ≥ 45 years
* Have given their consent to participate in the study
* Subjects who have a smartphone

Exclusion Criteria:

* Current or previous cardiovascular disease (personal history of myocardial infarction, angina pectoris, arterial revascularization procedures, stroke, TIA, peripheral artery disease)
* Psychiatric disorders
* Participation in other clinical trials

Primary outcomes:
measure: Cardiovascular risk as assessed by Modified Moli-Sani risk score in the Italian population
timeFrame: 12 months
measure: Long-term CV clinical outcome at 7 years follow-up
timeFrame: 7 years
Secondary outcomes:
measure: Change of a combined endpoint including hypertension, diabetes, hypercholesterolemia
timeFrame: 12 months
measure: Systolic and diastolic blood pressure (mmHg)
timeFrame: 12 months
measure: HDL-C, LDL-C, and triglycerides (mg/dL)
timeFrame: 12 months
measure: HbA1c (%)
timeFrame: 12 months
measure: Body weight (kg)
timeFrame: 12 months
measure: Physical activity (IPAQ questionnaire)
timeFrame: 12 months
measure: Mediterranean diet adherence (PREDIMED questionnaire)
timeFrame: 12 months
measure: Mediterranean diet adherence (Moli-Sani questionnaire)
timeFrame: 12 months
measure: Smoking status
timeFrame: 12 months
measure: Alcohol intake
timeFrame: 12 months
measure: Salt intake (MiniSal questionnaire)
timeFrame: 12 months
measure: Stress (Perceived Stress Scale; PSS)
timeFrame: 12 months
measure: Psychological distress (PHQ 4 questionnaire)
timeFrame: 12 months
measure: Anxiety (PHQ 4 questionnaire)
timeFrame: 12 months
measure: Depression (PHQ 4 questionnaire)
timeFrame: 12 months
measure: Multidimensional Health Locus of Control Scale (MHLCS) - Internality
timeFrame: 12 months
measure: Multidimensional Health Locus of Control Scale (MHLCS) - Powerful Others Externality
timeFrame: 12 months
measure: Multidimensional Health Locus of Control Scale (MHLCS) - Chance Externality
timeFrame: 12 months
measure: General Self Efficacy (GSE Scale)
timeFrame: 12 months
measure: Risk propensity (RPS Scale)
timeFrame: 12 months
measure: Sleep quality (Pittsburgh Sleep Quality Index)
timeFrame: 12 months
measure: Subjects' adherence to data recording
timeFrame: 12 months
measure: Interruptions in the use of the mHealth App
timeFrame: 12 months
measure: Adherence to recommended therapies
timeFrame: 12 months
measure: Cost/effectiveness of intervention
timeFrame: 7 years
measure: House ownership as socioeconomic status indicator
timeFrame: 7 years
measure: Type of residence as socioeconomic status indicator
timeFrame: 7 years
measure: Education as socioeconomic status indicator
timeFrame: 7 years
measure: Employment status as socioeconomic status indicator
timeFrame: 7 years
measure: Type of profession as socioeconomic status indicator
timeFrame: 7 years
measure: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of hospitalization (questionnaire)
timeFrame: 7 years
measure: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of symptoms (questionnaire)
timeFrame: 7 years
measure: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of asymptomatic disease (questionnaire)
timeFrame: 7 years
measure: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - history of vaccination (questionnaire)
timeFrame: 7 years
Other outcomes:
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in Oral Glucose Tolerance Test (OGTT) response in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in insulinemia in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in high-sensitivity C-reactive protein (hs-CRP) in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in microalbuminuria in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in Estimated Glomerular Filtration Rate (eGFR) in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in additional lipid parameters in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in diabetes diagnosis in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): markers of carotid subclinical atherosclerosis in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): carotid plaque area in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): carotid plaque volume in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): carotid wall echolucency in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): endothelial function in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): peripheral atherosclerosis in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): diabetic retinopathy in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): Long-term clinical outcome in the CV-PREVITAL PREDIABETES sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change of modifiable lifestyle-related cardiovascular risk factor such as smoking status, unhealthy diet and sedentary life in subjects of the Auxologico sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in 24-h blood pressure in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in body mass index in obese/overweight subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in sleep quality in subjects with sleep complaints
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in ambulatory blood pressure variables in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12- month change in dipping status in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in dietary salt intake in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change of cardiovascular risk (in hypertensive and obese/overweight subjects)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in microalbuminuria in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in creatinine in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in eGFR in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in left ventricular hypertrophy in hypertensive subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in acid uric level in hypertensive and obese/overweight subjects
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in fasting insulinemia (in obese/overweight subjects)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in fasting glucose levels (in obese/overweight subjects)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in waist circumference (in obese/overweight subjects)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month changes in waist/hips ratio (in obese/overweight subjects)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in Epworth Sleepness scale (ESS) questionnaire score (in subjects with sleep complaints)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in obstructive sleep apnea (OSA) diagnosis (in subjects with sleep complaints)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in positive airway pressure (PAP) treatment (in subjects with OSA treated with PAP therapy)
timeFrame: 12 months
measure: Ancillary study of UO-2 (IRCCS Istituto Auxologico Italiano): 12-month change in PAP treatment usage (in subjects with OSA treated with PAP therapy)
timeFrame: 12 months
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): 12-month change from baseline of LDL-cholesterol levels (powered primary outcome) in the CV-PREVITAL coronary calcium score sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): Rate of statin and aspirin therapy initiation in the CV-PREVITAL coronary calcium score sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS):12-month change in lipid biomarkers in the CV-PREVITAL coronary calcium score sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): SNPs associated with severe coronary artery calcification
timeFrame: 12 months
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): Incremental effectiveness, as assessed by healthy quality-adjusted life years (QALYs), of screening by CT scanning for coronary calcium score
timeFrame: 7 years
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): Incremental cost effectiveness ratio (ICERs) of screening by CT scanning for coronary calcium score
timeFrame: 7 years
measure: Ancillary study of UO-3 (Humanitas Research Hospital IRCCS): long-term clinical outcome in the CV-PREVITAL coronary calcium score sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in additional lipid parameters in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in glycemia in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in Brain Natriuretic Peptide (BNP) in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in creatinine evaluation in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in eGFR evaluation in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in microalbuminuria in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in hs-CRP in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in Interleukin 6 (IL-6) and Interleukin 1 beta (IL-1 beta) in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change in enzymatic tests in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of Intimal-Media Thickness in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of Intercellular adhesion molecule (ICAM) and Vascular Cell Adhesion Molecule (VCAM) in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of Ankle Brachial Index in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of total 10 year cardiovascular risk in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of quality of life in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): 12-month change of psychological conditions risk in the sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): Coronary Calcium Score (Hounsfield units)
timeFrame: 12 months
measure: Ancillary study of UO-5 (IRCCS MultiMedica): Long-term clinical outcome in the sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in hs-CRP in the CV-PREVITAL Neuromed sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in eGFR in the CV-PREVITAL Neuromed sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in additional dietary habits assessed in the CV-PREVITAL Neuromed sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-6 (IRCCS Neuromed): 12-month change in additional psycho-emotional indexes assessed in the CV-PREVITAL Neuromed sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-6 (IRCCS Neuromed): Determinants of dietary changes in the CV-PREVITAL Neuromed sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of insulinemia in the CV-PREVITAL San Donato cohort
timeFrame: month 0
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of Homocysteine in the CV-PREVITAL San Donato cohort
timeFrame: month 0
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of CRP in the CV-PREVITAL San Donato cohort
timeFrame: month 0
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of blood sodium and potassium levels in the CV-PREVITAL San Donato cohort
timeFrame: month 0
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline analysis of sRAGE and IL-6 in the CV-PREVITAL San Donato cohort
timeFrame: month 0
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): 12-month change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in the CV-PREVITAL San Donato cohort
timeFrame: 12 months
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): 12-month change in thyroid stimulating hormone (TSH) in the CV-PREVITAL San Donato cohort
timeFrame: 12 months
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline relative wall thickness (ratio), E/A (ratio), and E/e' (ratio) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Heart Mass (g) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline end-diastolic volume (ml), end-systolic volume (ml) and left atrial volume (ml) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Ejection Fraction (EF; %) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline maximal tricuspid regurgitation velocity (TRV max) (m/s) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline epicardial adipose tissue (mm) in the CV-PREVITAL San Donato cohort as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Carotid Artery Ultrasound imagining markers (IMT and plaques thickness) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Carotid Artery Ultrasound imagining markers (Presence/absence of plaques) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-7 (IRCCS Policlinico San Donato): Baseline Carotid Artery Ultrasound imagining markers (total plaque area) as predictor of cardiovascular events in the CV-PREVITAL San Donato cohort
timeFrame: 7 years
measure: Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): Occurrence of cardiovascular events in the CV-PREVITAL MAUGERI sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): Occurrence of new diagnosis of organ damage in the CV-PREVITAL MAUGERI sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): change in ankle brachial index (ABI) in the CV-PREVITAL MAUGERI sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): change in coronary calcium score in the CV-PREVITAL MAUGERI sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-8 (Istituti Clinici Scientifici Maugeri IRCCS): change in markers of carotid damage in the CV-PREVITAL MAUGERI sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-9 (ISMETT): 12-month change in coronary calcium score in the two arms in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (ISMETT): 12-month change in myocardial fibrosis in the two arms in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in biomarker of stress and heart failure in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in NT-proBN in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in Na and K levels in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in homocysteine levels in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in serum iron in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in ferritin in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): 12-month change in transferrin in CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): platelet and white blood cell count in the CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): red blood cell (RBC) count in the CV-PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): hemoglobin (Hb) in the CV-PREVITAL ISMETT sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): hematocrit (HCT) in the CV-PREVITAL ISMETT sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): effect of specific cardiovascular risk factors on coronary calcium score in the CV PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): effect of specific cardiovascular risk factors on myocardial fibrosis in the CV PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-9 (IRCCS ISMETT): effect of specific cardiovascular risk factors on biomarkers of stress and heart failure in the CV PREVITAL ISMETT cohort
timeFrame: 12 months
measure: Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): Prevalence of abdominal aortic aneurysms in the CV-PREVITAL San Martino sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): Prevalence of iliac artery aneurysms in the CV-PREVITAL San Martino sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): Prevalence of carotid artery stenosis in the CV-PREVITAL San Martino sub-study cohort.
timeFrame: month 0
measure: Ancillary study of UO-10 (Ospedale Policlinico San Martino IRCCS): risk stratification for cardiovascular disease in the CV-PREVITAL San Martino sub-study cohort.
timeFrame: month 0
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in markers of carotid damage (intimal-media thickness and plaques thickness) in the two arms in CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in markers of carotid damage (Presence/absence of plaques) in the two arms in CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in Fibroscan CAP Score as a non-invasive biomarker of liver damage in the CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in Fibrosis-4 Index (FIB-4) as non-invasive biomarker of liver damage in the CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in circulating biomarker of lipotoxicity (Interleukin-32) in the CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in microalbuminuria in the CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in enzymatic tests in the CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 12-month change in insulinemia in the CV-PREVITAL blood donor sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): characterization of the coagulation balance in the CV-PREVITAL blood donor sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): D-Dimer levels in the CV-PREVITAL blood donor sub-study cohort
timeFrame: month 0
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in taxonomic characterization of the intestinal microbiome in feces in a subsample of 200 participants
timeFrame: 7 years
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in characterization of the intestinal microbiome in feces in a subsample of 200 participants
timeFrame: 7 years
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in the intestinal microbiome in feces in a subsample of 200 participants (TMAO)
timeFrame: 7 years
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in characterization of the intestinal microbiome in feces in a subsample of 200 participants (branched-chain amino acid, BCAAs)
timeFrame: 7 years
measure: Ancillary study of UO-11 (IRCCS Ca' Granda): 7-year change in characterization of the intestinal microbiome in feces in a subsample of 200 participants (aromatic amino acid, AAAs)
timeFrame: 7 years
measure: Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in thickness of the medium-intimal complex of the common carotid in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in additional lipid parameters in the CV-PREVITAL-Inflammation and Microbiota sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in hs-CRP in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in inflammatory mediators in the CV-PREVITAL-Inflammation and Microbiota sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in serum levels of trimethylamine oxide (TMAO) in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-12 (IRCCS Gemelli): 12-month change in intestinal microbiome composition and intestinal permeability in the CV-PREVITALInflammation and Microbiota sub-study cohort
timeFrame: 12 months
measure: Ancillary study of UO-12 (IRCCS Gemelli):Long-term clinical outcome in the CV-PREVITAL Inflammation and Microbiota sub-study cohort
timeFrame: 7 years
measure: Ancillary study of UO-13 (IRCCS San Matteo): NGS multigene analysis for the early diagnosis of diabetes
timeFrame: 7 years
measure: Ancillary study of UO-13 (IRCCS San Matteo): NGS multigene analysis for the diagnosis of familial dyslipidemia
timeFrame: 7 years
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of physical activity in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): amount of daily physical activity in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 3 months and 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Mediterranean diet adherence by MDS questioner in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Mediterranean diet adherence by PREDIMED questioner in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Mediterranean diet adherence by Moli-Sani questioner in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): salt intake in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of alcohol intake in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of stress (Perceived Stress Scale; PSS) in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of psychological distress (PHQ 4 questioner) in the CV-PREVITAL Exercise sub- study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of anxiety (PHQ 4 questioner) in the CV-PREVITAL Exercise sub- study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of depression (PHQ 4 questioner) in the CV-PREVITAL Exercise sub- study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of General Self Efficacy (GSE Scale) in the CV-PREVITAL Exercise sub- study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Multidimensional Health Locus of Control Scale (MHLCS) - Internality in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Multidimensional Health Locus of Control Scale (MHLCS) - Powerful Others Externality in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Multidimensional Health Locus of Control Scale (MHLCS) - Chance Externality in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of Risk propensity in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of sleep quality in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of HDL-C, LDL-C, triglycerides and blood glucose in the CV- PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): 6 month-evaluation of HbA1c in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): red blood cell (RBC) count in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): platelet and white blood cell count in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): differential WBC count in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): hematocrit (HCT) and RBC Distribution Width (RDW) in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): mean corpuscular volume (MCV) and mean platelet volume (MPV) in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
measure: Ancillary study of UO-14 (IRCCS San Raffaele Roma): mean corpuscular hemoglobin (MCH) in the CV-PREVITAL Exercise sub-study cohort
timeFrame: 6 months
Locations:
city: Scafa
country: Italy
facility: Nucleo Cure Primarie Val Pescara
state: Abruzzo
city: Reggio Calabria
country: Italy
facility: Panacea Medical Group
state: Calabria
city: Benevento
country: Italy
facility: Samnium Medica
state: Campania
city: Salerno
country: Italy
facility: MEDINCO'
state: Campania
city: Salerno
country: Italy
facility: Magna Grecia
state: Campania
city: Carpi
country: Italy
facility: Meditem
state: Emilia Romagna
city: Pradamano
country: Italy
facility: MAF
state: Friuli Venezia-Giulia
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
state: Isernia
city: Roma
country: Italy
facility: Arvamed
state: Lazio
city: Roma
country: Italy
facility: IRCCS San Raffaele Roma
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Genova
country: Italy
facility: MediCoop Genova
state: Liguria
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
state: Liguria
city: Bergamo
country: Italy
facility: IML
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: Lombardia
city: Milano
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: Lombardia
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas Research Hospital IRCCS
state: Lombardia
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
city: Sesto San Giovanni
country: Italy
facility: IRCCS MultiMedica SpA
state: Lombardia
city: Appiano Gentile
country: Italy
facility: Medici Insubria
state: Lombardy
city: Legnano
country: Italy
facility: GST
state: Lombardy
city: Milano
country: Italy
facility: CMMC
state: Lombardy
city: Mozzate
country: Italy
facility: Cosma 2000
state: Lombardy
city: Soresina
country: Italy
facility: CMMG Soresina
state: Lombardy
city: Martano
country: Italy
facility: Progetto Salute Soc. Coop
state: Puglia
city: Palermo
country: Italy
facility: IRCCS Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
state: Sicilia
city: Seravezza
country: Italy
facility: ARS Medica
state: Toscana
city: Siena
country: Italy
facility: Medici 2000
state: Toscana
city: Padova
country: Italy
facility: Medigen Salute
state: Veneto
Study officials:
affiliation: Centro Cardiologico Monzino IRCCS
name: Giulio Pompilio, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Auxologico Italiano IRCCS
name: Gianfranco Parati, Professor
role: PRINCIPAL_INVESTIGATOR
References: