The Moli-sani Study

Completed

• Conditions: Cardiovascular Diseases; Neurodegenerative Diseases; Diabetes; Pulmonary Disease; Cardiovascular Risk Factor; Cancer

• Registration Number: NCT03242109
• Lead Sponsor: Neuromed IRCCS

Brief Summary

Cardiovascular disease and malignancies account for more than 70% of all causes of mortality and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle, that often defines the line between health and sickness. So far studies aiming at identifying risk factors have mainly come from Northern Europe and the USA. It was to understand this balance between genetics and environmental determinants better, and to tailor appropriate preventive strategies for Italian and other Southern European populations, that the Moli-sani study was launched, transforming a small Italian region into a large scientific laboratory: the "Molise lab".

Each participant received a thorough medical check-up at no cost to either him/her or the national health service, resulting in thousands of hours of free public health care. With a completely computerized system, Moli-sani is a "paperless" study, in which researchers and participants communicate using recently developed technologies such as mobile phone text messages (SMS). The biological data bank (the "MoliBank") is one of the largest in Europe. Paying particular attention towards innovation and new technologies, the Moli-sani study has placed itself at the cutting edge of a new paradigm crossing research and prevention

Detailed Description

The cohort of the Moli-sani study has recruited 24,325 persons, aged \>35 years, resident in the Molise region.The latter covers an area of 4,438 Km2, including 136 towns. Participants are recruited from city-hall registries by a multistage sampling. Firstly townships were sampled in three major areas of Molise region, starting from the main cities (Campobasso, Termoli, Isernia) by cluster sampling, then, within each township, participants are selected by simple random sampling, using electronically generated numbers.Exclusion criteria are pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form. All subjects identified are sent a letter inviting them to participate in the project, followed a few days later by a phone call. The recruitment started in the area of Campobasso, then it moved to the areas of Termoli.

Study Timeline

• Study Start: 2005-03-01
• Primary Completion: 2010-04-30
• Study Completion: 2010-04-30
• Status Verified: 2017-07
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-08
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24325

Inclusion Criteria

• Resident in the Molise region (Italy), aged >35.

Exclusion Criteria

• pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary cardiovascular diseases	10 years	Primary fatal and nonfatal incident cases of CHD (unstable angina, myocardial infarction, coronary revascularization and sudden death for unspecified cardiac event) and cerebrovascular disease that occurred in the cohort during follow-up
Diabetes	10 years	Primary incident cases of diabetes that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry or pharmacological prescription registry. Diabetes onset is defined as blood glucose ≥126 mg/dl or by use of specific pharmacological treatment
Cancer	10 years	Primary fatal and nonfatal incident cases of cancer that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry
Heart failure	10 years	Primary fatal and nonfatal incident cases of heart failure that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry
Atrial fibrillation	10 years	Primary fatal and nonfatal incident cases of atrial fibrillation that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

Trial Locations

Locations (1)

Irccs Neuromed; 🇮🇹 Pozzilli, Italy