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NESCAV Nutrition Environment and Cardiovascular Health (NESCAV)

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ClinicalTrials.gov Identifier: NCT01414179
Recruitment Status : Unknown
Verified August 2010 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Sponsor:
Collaborators:
CIC-P
European Regional Development Fund
Luxembourg Institute of Health
ULG Wallonie
Information provided by:
Central Hospital, Nancy, France

Tracking Information
First Submitted Date August 10, 2011
First Posted Date August 11, 2011
Last Update Posted Date August 11, 2011
Study Start Date October 2010
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NESCAV Nutrition Environment and Cardiovascular Health
Official Title Nutrition Environnement et Santé Cardio Vasculaire NESCAV
Brief 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. 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 Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Probability Sample
Study Population general population
Condition Cardiovascular Pathology
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August¬†10,¬†2011)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • taking part of the study refusal
  • signature assent refusal
  • pregancy
  • minor people
  • People under supervision or under trusteeship
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01414179
Other Study ID Numbers 2010-A00549-30
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pr. Faiez ZANNAD, CIC-P, CHU de Nancy
Study Sponsor Central Hospital, Nancy, France
Collaborators
  • CIC-P
  • European Regional Development Fund
  • Luxembourg Institute of Health
  • ULG Wallonie
Investigators
Principal Investigator: Faiez ZANNAD, PU-PH CIC-P
PRS Account Central Hospital, Nancy, France
Verification Date August 2010