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Completed

NCT Number: NCT03242109

The Moli-sani Study

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

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Key information

Conditions

Cardiovascular Diseases Cancer Cardiovascular Risk Factor Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Lung Diseases Metabolic Diseases Neoplasms Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Pulmonary Disease Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Neuromed

Pozzilli, 86067, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary cardiovascular diseases

    Time frame: 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

  2. Cancer

    Time frame: 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

  3. Heart failure

    Time frame: 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

  4. Atrial fibrillation

    Time frame: 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

  5. Diabetes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Neuromed IRCCS

Other

Registry information

Official study title

An Epidemiological Study of Risk Factors for Cardiovascular Disease and Tumors in an Adult Population of the Molise Region

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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