An observational study in Outcome, sponsored by Guido Iaccarino. Status unknown at 1 site in Italy. Open to participants aged 14 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-09.
Sponsored by Guido Iaccarino · Observational
The present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). The study was approved by the relevant institutional Ethical Committee of Salerno University.
In occasion of the World Hypertension Day in may , boots are organized in the major squares of the southern italy villages, and volunteers of the Medical School of Salerno collect through means of questionnaires, anamnestic data and dietary habits, and measure blood pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn from the antecubital vein and blood is stored for biochemical analysis at the University Hospital Centralized Service. Data are digitally stored for analysis.
Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol, systolic BP and cigarette smoking pre-existing conditions and way of life are used for the calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score. Familiarity for cardiovascular disease is defined as cardiovascular events in parents and siblings less than 50 years old.
The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the last meal was recorded during the data collection. Blood glucose, insulin, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed. Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) .
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 98 across 1,235 observational studies indexed under Motor Activity.
Browse Motor Activity studies →Guido Iaccarino is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint.
cardiovascular events
Presence of events in the anamnesis of subjects enrolled
Time frame: 10 year
cardiovascular risk
Framingham Risk Score
Time frame: 10 years
vitamin D profile
vitamin d serum levels will be assessed and compared to the life style
Time frame: 10 years
vitamin B12 profile
vitamin b12 serum levels will be assessed and compared to the life style
Time frame: 10 years
Folic Acid profile
folic acid serum levels will be assessed and compared to the life style
Time frame: 10 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2014 (actual). Primary completion is estimated for Jul 2020, 74 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Guido Iaccarino