Cardiovascular PathologyNESCAVNCT01414179
NESCAV Nutrition Environment and Cardiovascular Health
An observational study of Cardiovascular Pathology, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy lifestyles. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Pathology
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Dec 2011
- 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: general population
Who may be able to join
- men or women aged 18 till 69 years old
- living in Lorraine since 5 years
- speaking and understanding French language
- having signed the assent
- Having a social security number
Who cannot join
- taking part of the study refusal
- signature assent refusal
- pregancy
- minor people
- People under supervision or under trusteeship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre médecine Preventive
Vandœuvre-lès-Nancy, France, 54500
Celine Hertz, +33 3 83 15 73 12, cel.hertz@chu-nancy.fr
About this study
Official title: Nutrition Environnement et Santé Cardio Vasculaire NESCAV
Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy lifestyles. To prevent occurred of the cardiovascular affections is, more than ever, a major goal of Public health. The transborder "Great Area", localised zone in the middle of Europe between the very high cardiovascular risks of the North and the weaker risks of the South, constitutes a zone privileged for the action against the cardiovascular diseases. However, there to date does not exist any joint action in this geographical area. The Public Research centre of the Health of the Grand-Duchy of Luxembourg, the School of Public health of the University of Liege, the Clinical Center of Investigation of the University hospital of Nancy and the University hospital of the Saar wish to be linked and mutualiser their means available and their complementary competences in order to evaluate and to act on the cardiovascular health of the citizens of the "Great Area". Over one 3 years period the Nutrition project, Environment and Cardiovascular Health (NESCAV) aims at creating on the level of the Great Area a transborder alliance of prevention and promotion of cardiovascular health. This great multicentric transverse investigation and poly-set of themes will make it possible to collect relevant data on cardiovascular health of the population of the Great area.
Objective of this biomedical research project: It is about multicentric, transverse a Européenne epidemiological study aiming, through biological questionnaires and analyses, to collect information on the cardiovascular risk factors within the Great Area.
Read the detailed description
Methods: In Lorraine, this study will be carried out on 800 subjects from 18 to 69 years taking part simultaneously in a quinquennial assessment of preventive medicine (CPAM), in the Centers of Preventive medicine (CMP) of Nancy and Longwy. The study will proceed on 1 year and six months, the recruitment of the volunteers will finish with the end of the year 2011. Data collected: General questionnaire, medical examination Quantification of the nutritional contributions Perception of the participant on the methods of assumption of responsibility of various risk factors cardiovascular Blood and urinary biological taking away: glycemia, HbA1C, insulin (specific study analyzes), total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoproteines A1 and B, numeration of blood picture, creatinin, uric acid, gamma WP, GOT, GPT, CRP; and a urinary collection (a micturition) in order to proportion the microalbuminurie. A plasmathèque will be made up, in order to measure later on biomarqueurs of the cardiovascular risk (biological collection stored with the CIC). A measurement of pollutants and poisons will be carried out starting from taking away of hair. (analyzes realized in Luxembourg) Data analysis: All the relative data with the participants will be anonymisées with the CMP before export to the CIC. These anonymized data will also be the subject of a treatment computerized in the countries taking part in the study, and a database common to the partners of the Great area will be made up, in order to compare the characteristics of the 3 transborder populations.
- Conditions
- Cardiovascular Pathology
- Keywords
- nutrition, environnement, cardiovascular pathology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular PathologyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- CIC-P, European Regional Development Fund, Luxembourg Institute of Health, ULG Wallonie
- Investigators
- Faiez ZANNAD, PU-PH, Principal investigator, CIC-P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414179
- Sponsor's protocol ID
- 2010-A00549-30
- Acronym
- NESCAV
- Status last verified
- Aug 2010
- First submitted
- 10 Aug 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Environnement et Santé Cardio Vasculaire NESCAV
- ClinicalTrials.gov ID
- NCT01414179
- Acronym / sponsor ID
- NESCAV / 2010-A00549-30
- Conditions
- Cardiovascular Pathology
- Keywords
- nutrition, environnement, cardiovascular pathology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- CIC-P, European Regional Development Fund, Luxembourg Institute of Health, ULG Wallonie
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- 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.
Introduction. The cardiovascular diseases, at the origin of 4 deaths out of 10, remain the leading cause of mortality in Europe. According to WHO, this tendency will spread in 2020 on a worldwide scale. These pathologies are avoidable on the whole by the adoption of healthy lifestyles. To prevent occurred of the cardiovascular affections is, more than ever, a major goal of Public health. The transborder "Great Area", localised zone in the middle of Europe between the very high cardiovascular risks of the North and the weaker risks of the South, constitutes a zone privileged for the action against the cardiovascular diseases. However, there to date does not exist any joint action in this geographical area. The Public Research centre of the Health of the Grand-Duchy of Luxembourg, the School of Public health of the University of Liege, the Clinical Center of Investigation of the University hospital of Nancy and the University hospital of the Saar wish to be linked and mutualiser their means available and their complementary competences in order to evaluate and to act on the cardiovascular health of the citizens of the "Great Area". Over one 3 years period the Nutrition project, Environment and Cardiovascular Health (NESCAV) aims at creating on the level of the Great Area a transborder alliance of prevention and promotion of cardiovascular health. This great multicentric transverse investigation and poly-set of themes will make it possible to collect relevant data on cardiovascular health of the population of the Great area.
Objective of this biomedical research project: It is about multicentric, transverse a Européenne epidemiological study aiming, through biological questionnaires and analyses, to collect information on the cardiovascular risk factors within the Great Area.
Detailed description
Methods: In Lorraine, this study will be carried out on 800 subjects from 18 to 69 years taking part simultaneously in a quinquennial assessment of preventive medicine (CPAM), in the Centers of Preventive medicine (CMP) of Nancy and Longwy. The study will proceed on 1 year and six months, the recruitment of the volunteers will finish with the end of the year 2011. Data collected: General questionnaire, medical examination Quantification of the nutritional contributions Perception of the participant on the methods of assumption of responsibility of various risk factors cardiovascular Blood and urinary biological taking away: glycemia, HbA1C, insulin (specific study analyzes), total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoproteines A1 and B, numeration of blood picture, creatinin, uric acid, gamma WP, GOT, GPT, CRP; and a urinary collection (a micturition) in order to proportion the microalbuminurie. A plasmathèque will be made up, in order to measure later on biomarqueurs of the cardiovascular risk (biological collection stored with the CIC). A measurement of pollutants and poisons will be carried out starting from taking away of hair. (analyzes realized in Luxembourg) Data analysis: All the relative data with the participants will be anonymisées with the CMP before export to the CIC. These anonymized data will also be the subject of a treatment computerized in the countries taking part in the study, and a database common to the partners of the Great area will be made up, in order to compare the characteristics of the 3 transborder populations.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general population
Key inclusion criteria (5 listed)
- men or women aged 18 till 69 years old
- living in Lorraine since 5 years
- speaking and understanding French language
- having signed the assent
- Having a social security number
Key exclusion criteria (5 listed)
- taking part of the study refusal
- signature assent refusal
- pregancy
- minor people
- People under supervision or under trusteeship
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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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.
Faiez ZANNAD, PU-PH principal investigator
CIC-P
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 Pathology, run by Central Hospital, Nancy, France at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 2011. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celine Hertz (+33 3 83 15 73 12, cel.hertz@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 11 Aug 2011.