Cardiovascular DiseasesNCT03242109
The Moli-sani Study
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Neuromed IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Cancer
- How many people
- 24,325 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2005to 30 Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Adult, Older adult
Study population: Moli-sani is a population-based cohort study that recruited, between March 2005 and April 2010, 24,325 men and women at random from individuals aged 35 years or older resident in the Molise region, to investigate genetic and environmental risk factors for cardiovascular, cerebrovascular and tumour diseases.
Who may be able to join
- Resident in the Molise region (Italy), aged >35.
Who cannot join
- pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Epidemiological Study of Risk Factors for Cardiovascular Disease and Tumors in an Adult Population of the Molise Region
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
Read the 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.
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, Cancer, Neurodegenerative Diseases, Diabetes, Pulmonary Disease
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Neurodegenerative Diseases, Diabetes Mellitus, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary cardiovascular diseases
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
Measured: 10 years
Cancer
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
Measured: 10 years
Heart failure
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
Measured: 10 years
Atrial fibrillation
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
Measured: 10 years
Diabetes
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Mar 2005
- Primary completion30 Apr 2010
- Study completion30 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Licia Iacoviello, Neuromed IRCCS
- Investigators
- Licia Iacoviello, MD, PhD, Principal investigator, Department of Epidemiology and Prevention, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242109
- Sponsor's protocol ID
- 50/17
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sumbmission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
Publications
Pounis G, Tabolacci C, Costanzo S, Cordella M, Bonaccio M, Rago L, D'Arcangelo D, Filippo Di Castelnuovo A, de Gaetano G, Donati MB, Iacoviello L, Facchiano F; Moli-sani study investigators. Reduction by coffee consumption of prostate cancer risk: Evidence from the Moli-sani cohort and cellular models. Int J Cancer. 2017 Jul 1;141(1):72-82. doi: 10.1002/ijc.30720. Epub 2017 Apr 24.
PubMed 28436066Bonaccio M, Di Castelnuovo A, Costanzo S, de Curtis A, Persichillo M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; MOLI-SANI study Investigators. Mean platelet volume is associated with lower risk of overall and non-vascular mortality in a general population. Results from the Moli-sani study. Thromb Haemost. 2017 Jun 2;117(6):1129-1140. doi: 10.1160/TH16-12-0974. Epub 2017 Mar 30.
PubMed 28357442
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study of Risk Factors for Cardiovascular Disease and Tumors in an Adult Population of the Molise Region
- ClinicalTrials.gov ID
- NCT03242109
- Acronym / sponsor ID
- 50/17
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, Cancer, Neurodegenerative Diseases, Diabetes, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,325 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2005 (actual)
- Primary completion
- 30 Apr 2010 (actual)
- Study completion
- 30 Apr 2010 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Moli-sani is a population-based cohort study that recruited, between March 2005 and April 2010, 24,325 men and women at random from individuals aged 35 years or older resident in the Molise region, to investigate genetic and environmental risk factors for cardiovascular, cerebrovascular and tumour diseases.
Key inclusion criteria (1 listed)
- Resident in the Molise region (Italy), aged >35.
Key exclusion criteria (1 listed)
- pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Results publication: PubMed 28436066Pounis G, Tabolacci C, Costanzo S, Cordella M, Bonaccio M, Rago L, D'Arcangelo D, Filippo Di Castelnuovo A, de Gaetano G, Donati MB, Iacoviello L, Facchiano F; Moli-sani study investigators. Reduction by coffee consumption of prostate cancer risk: Evidence from the Moli-sani cohort and cellular models. Int J Cancer. 2017 Jul 1;141(1):72-82. doi: 10.1002/ijc.30720. Epub 2017 Apr 24.
- Results publication: PubMed 28357442Bonaccio M, Di Castelnuovo A, Costanzo S, de Curtis A, Persichillo M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; MOLI-SANI study Investigators. Mean platelet volume is associated with lower risk of overall and non-vascular mortality in a general population. Results from the Moli-sani study. Thromb Haemost. 2017 Jun 2;117(6):1129-1140. doi: 10.1160/TH16-12-0974. Epub 2017 Mar 30.
- Individual participant dataSharing planned: Yes. sumbmission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Licia Iacoviello, MD, PhD principal investigator
Department of Epidemiology and Prevention, IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by Neuromed IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary cardiovascular diseases (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03242109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.