HÉRITABILITÉ FAMILIALE, INTERACTIONS GÈNE-GÈNE ET GÈNE-ENVIRONNEMENT DANS LE DOMAINE DES MALADIES CARDIOVASCULAIRES ET RENALES. Cinquième Visite de la Cohorte STANISLAS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Ratio E/e' measured by echocardiography
研究概览
简要总结
The Stanislas Cohort is a monocentric familial longitudinal cohort originally comprised of 1006 families consisting of two parents and at least two biological children and deemed healthy, recruited in 1993-1995 at the Centre for Preventive Medicine of Nancy. This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases. The 5th visit of the STANISLAS Cohort will allow a better evaluation of the cardiovascular ageing of the population and the transition toward cardiovascular or renal diseases in relation with their genetic profile and environment.
详细描述
The main objective of the STANISLAS cohort is to identify the factors associated with cardiovascular aging (assessed through the study of the degradation of morphological and functional parameters of the heart and vascular systems).
Data (clinical, biological, morphological, genetic and lifestyle) from previous visits (the first having been initiated in the mid-1990s) will be considered as exposure and / or adjustment variables.
The exposure variables of interest will be:
- The components of metabolic syndrome (MS),
- Genetic determinants, through an approach of family segregation and candidate genes,
- Multi-omic biomarkers analyzed from the biological collection of the first assessments of the cohort
- Food intake, nutrition and eating behavior
The secondary objectives are
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged over 18
- •Person who participated in the Stanislas Cohort
- •Person affiliated to a social security scheme or beneficiary of such a scheme
- •Person having received complete information on the organization of the research and having signed an informed consent
排除标准
- •Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1
- •Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code:
- •Pregnant woman, parturient or nursing mother
- •Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- •Person of full age unable to express consent
研究组 & 干预措施
Healthy volonteer
干预措施: 24 hours urinary collection (Biological)
Healthy volonteer
干预措施: Blood and urine samples (Biological)
Healthy volonteer
干预措施: Blood samples (Genetic)
Healthy volonteer
干预措施: Cardiovascular assessment (Other)
Healthy volonteer
干预措施: Dietary intake (Behavioral)
Healthy volonteer
干预措施: Anthropometric parameters (Other)
Healthy volonteer
干预措施: Assessment of compliance with antihypertensive treatments for treated participants (Behavioral)
Healthy volonteer
干预措施: Ambulatory 24 hours measurment of blood pressure (Other)
Healthy volonteer
干预措施: Hemodynamic parameters (Other)
Healthy volonteer
干预措施: General questionnaires (Other)
Healthy volonteer
干预措施: Women specific questionnaire (Other)
Healthy volonteer
干预措施: Women specific questionnaire (Behavioral)
Healthy volonteer
干预措施: NYHA dyspnea questionnaire (Diagnostic Test)
Healthy volonteer
干预措施: Anxiety questionnaire (Behavioral)
Healthy volonteer
干预措施: Epworth Sleepiness Scale (Behavioral)
Healthy volonteer
干预措施: A questionnaire on the "perception of the management of cardiovascular risk factors" (Other)
Healthy volonteer
干预措施: A questionnaire on eating behaviors (Behavioral)
Healthy volonteer
干预措施: A questionnaire on eating habits to determine consumer profiles (Behavioral)
Healthy volonteer
干预措施: A questionnaire on food supplements use (Dietary Supplement)
Healthy volonteer
干预措施: SARS-CoV-2 Infection Questionnaire (Other)
Healthy volonteer
干预措施: Instantaneous expired air analysis (Other)
Healthy volonteer
干预措施: Capillary sampling (Biological)
结局指标
主要结局
Ratio E/e' measured by echocardiography
时间窗: Baseline
Indexed left ventricular mass measured by echocardiography
时间窗: Baseline
Tissue doppler imaging e' wave measured by echocardiography
时间窗: Baseline
Left atrial volume measured by echocardiography
时间窗: Baseline
Central blood pressure
时间窗: Baseline
Left ventricular volume measured by echocardiography
时间窗: Baseline
Carotid intima media thickness measured by echotracking
时间窗: Baseline
Pulmonary congestion evaluated by lung ultrasound
时间窗: Baseline
Pulse wave velocity measured by Sphygmocor and Complior Analyse
时间窗: Baseline
次要结局
- Change in HbA1C(Baseline)
- Change in lipid parameters (LDL and HDL cholesterol)(Baseline)
- Occurrence of the following clinical CV events: Hospitalization for HF, HF not requiring hospitalization, Atrial fibrillation, Acute coronary syndrome, Coronary artery disease, Hypertension (requiring introduction of drug treatment), Stroke(Baseline)
- Proteinuria (on sample)(Baseline)
- Blood glucose(Baseline)
- General symptoms persisting beyond 8 weeks after SARS-CoV-2 infection such as: disabling asthenia, disabling dyspnea, cardiothoracic signs, arthromyalgia, neurocognitive disorders or anosmia(Baseline)
- Estimation of the glomerular filtration rate (CKD-EPI formula)(Baseline)
- Results of future relevant biomarker assays(Baseline)
研究者
Pr. Nicolas GIRERD
Coordinating doctor
Central Hospital, Nancy, France