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临床试验/NCT01391442
NCT01391442已完成不适用

Family Heritability, Investigating Gene-gene and Gene-environment Interactions in the Field of Cardiovascular Diseases - 4th VISIT (at 17 Years) of the STANISLAS COHORT

Pr. Nicolas GIRERD4 个研究点 分布在 1 个国家目标入组 1,705 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,705
试验地点
4
主要终点
investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases

研究概览

简要总结

The Stanislas Cohort is a monocentric familial longitudinal cohort comprised of 1006 families (4295 subjects) from the Nancy region recruited in 1993-1995 at the Centre for Preventive Medicine (Centre de Médecine Préventive, CMP), Vandoeuvre lès Nancy for a 5-year periodic health examination, under the auspices of the Caisse Nationale d'Assurance Maladie (CNAM).

This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases, based on the study of inter-individual variability and familial segregation analysis of biological and morphological intermediate phenotypes of cardiovascular risk. The longitudinal nature of this study should enable to take into account the evolution of intermediate phenotypes related to genetic factors throughout the follow-up period. The families, consisting of two parents and at least two biological children, were deemed healthy, free of declared acute and/or chronic illness, in order to assess the effect of genetics on the variability of intermediate phenotypes studied under physiological conditions (without the influence, in the absence) of pathology.

The Stanislas Cohort is, both nationally and internationally, the only longitudinal familial cohort of supposedly healthy subjects on such a large scale.

Brief summary of ancillary study "Cardiac Functional Indices Comparison Between MRI and Echocardiography" : the ESCIF study is an ancillary study of the Stanislas cohort aiming at comparing in a cohort of supposedly healthy subjects different cardiac functional indices between two different modalities : Echocardiography and MRI. Indeed, new cardiac functional indices have been recently developed in the scope of echocardiography and would be very useful in MRI. In echography they are computed either from tissue Doppler imaging or from a specific image analysis called speckle tracking. These two techniques are accessible in MRI with the Generalized Reconstruction by Inversion of Coupled Systems (GRICS) technology which provides a motion model from which strains and strain rates may be derived and which allow longer acquisition without the constraint of breath holding (mandatory to reach high temporal resolution).

详细描述

MAIN STUDY Follow-up visit No. 4 is currently being scheduled, and is planned between 2011 and 2016.

Objectives:

  • Conduct a fourth visit, in 2011-2016, enabling a follow-up at 17 years of the cohort population.

  • Enrich the sample collection with new biobanks and clinical phenotyping of the cohort by conducting selected specific investigations and supported by specific scientific hypotheses and protocols

  • Evaluate the long-term (follow-up, monitoring) of clinical, biological, morphological data by analyzing:

  • The influence of aging (average age of parents in 1993: 45 years and in 2010-2012: 62 years).

  • The incidence and changes in prevalence of cardiovascular risk factors comprising the metabolic syndrome (MS), and their familial segregation, since as early as the second visit, in some one hundred families, at least one family member presented a MS according the definition of the NCEP-ATPIII. Approximately 20% of adults had high blood pressure (hypertension), and 50% had a body mass index above 25 kg/m2.

  • The genetic and environmental determinants, through a multifaceted approach including familial segregation and candidate genes, the progression of cardiovascular risk and the incidence of cardiovascular diseases (vascular and coronary diseases, heart failure).

Methodology, Organization:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient having taken part in the STANISLAS troop,
  • At least 18 years old,
  • Written and signed enlightened assent,
  • Ensured social

排除标准

  • Patient unable to understand the informed consent,
  • patient under legal protection
  • STANISLAS ancillary study:
  • Study population = subgroup of 76 subjects from the Stanislas cohort
  • Eligibility:
  • being member of the Stanislas cohort and participating to 4th visit Specific written and signed enlightened consent for the ESCIF study
  • contraindications for MRI examination, possibility of pregnancy

结局指标

主要结局

investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases

时间窗: day 1

study of inter-individual variability and familial segregation analysis of biological and morphological intermediate phenotypes of cardiovascular risk

ESCIF ancillary study : pair-wise comparison of functional indices measured in MRI and echocardiography

时间窗: day 1

次要结局

  • ESCIF ancillary study : inter-observer reproducibility of each method (MRI and Echocardiography)(day 1)

研究者

发起方
Pr. Nicolas GIRERD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pr. Nicolas GIRERD

Clinical Professor

Central Hospital, Nancy, France

研究点 (4)

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