FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Identify the factors associated with a degradation of renal parameters (renal function and proteinuria). Identify the factors associated with a degradation of metabolic parameters. To assess the association between SARS-CoV-2 infection (questionnaire and serological approach) and cardiovascular and renal parameters Identify factors associated with the occurrence of clinical cardiovascular events. Association between Covid 19 events and general disabling symptoms Complete the cohort's biological collection for future biomarker assays related to previous objectives

Official Title
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HÉRITABILITÉ FAMILIALE, INTERACTIONS GÈNE-GÈNE ET GÈNE-ENVIRONNEMENT DANS LE DOMAINE DES MALADIES CARDIOVASCULAIRES ET RENALES. Cinquième Visite de la Cohorte STANISLAS

Conditions
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Cardiovascular Diseases, Cohort Studies, Genotype, Risk Factors, Nutrition

Intervention / Treatment
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* Biological: Blood and urine samples
* Genetic: Blood samples
* Other: Cardiovascular assessment
* Behavioral: Dietary intake
* Other: Anthropometric parameters
* Other: Hemodynamic parameters
* Other: Hemodynamic parameters
* Other: Hemodynamic parameters
* Other: Hemodynamic parameters
* Behavioral: Assessment of compliance with antihypertensive treatments for treated participants
* Other: Ambulatory 24 hours measurment of blood pressure
* Biological: 24 hours urinary collection
* Other: General questionnaires
* Other: Women specific questionnaire
* Behavioral: Women specific questionnaire
* Diagnostic Test: NYHA dyspnea questionnaire
* Behavioral: Anxiety questionnaire
* Behavioral: Epworth Sleepiness Scale
* Other: A questionnaire on the perception of the management of cardiovascular risk factors
* Behavioral: A questionnaire on eating behaviors
* Behavioral: A questionnaire on eating habits to determine consumer profiles
* Dietary Supplement: A questionnaire on food supplements use
* Other: SARS-CoV-2 Infection Questionnaire
* Other: Instantaneous expired air analysis
* Biological: Capillary sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volonteer<br> | Biological: Blood and urine samples<br>* Blood and urine samples<br>Genetic: Blood samples<br>* Blood samples<br>Other: Cardiovascular assessment<br>* Echocardiography, Lung ultrasound, pulse wave velocity, carotid stiffness and thickness, Central and peripheral blood pressure, carotid pulse pressure, abdominal aorta ultrasound, jugular vein ultrasound, liver elastography (Optional).<br>Behavioral: Dietary intake<br>* Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire<br>Other: Anthropometric parameters<br>* Measurement of height, weight, abdominal circumference, hip circumference, arm circumference<br>Other: Hemodynamic parameters<br>* Systolic pressure index measurement<br>Other: Hemodynamic parameters<br>* Heart rate measurements, blood pressure measurements, orthostatic BP measurements<br>Other: Hemodynamic parameters<br>* Blood pressure measurements by unattended BP monitor over 5 min<br>Other: Hemodynamic parameters<br>* Electrocardiogram<br>Behavioral: Assessment of compliance with antihypertensive treatments for treated participants<br>* EVALOBS scale and compliance questionnaire<br>Other: Ambulatory 24 hours measurment of blood pressure<br>* For the first 100 patients willing to participate<br>Biological: 24 hours urinary collection<br>* For the first 100 patients willing to participate. For biobank constitution and measurement of microalbuminuria, creatininuria, osmolarity, natriuresis, kaliuresis, urea, proteinuria and urine dipstick<br>Other: General questionnaires<br>* Collection of socio-demographic data such as age, level of education, profession, household income, smoking status, physical activity, perception of health, prematurity, height and weight at birth, family and personal history especially cardiovascular (history of stroke, myocardial infarction, heart failure, current pathologies, drugs, tobacco...)<br>Other: Women specific questionnaire<br>* Women specific questionnaire<br>Behavioral: Women specific questionnaire<br>* Women specific questionnaire<br>Diagnostic Test: NYHA dyspnea questionnaire<br>* Determination of NYHA class.<br>Behavioral: Anxiety questionnaire<br>* Assessment of anxiety<br>Behavioral: Epworth Sleepiness Scale<br>* sleep quality assessment<br>Other: A questionnaire on the perception of the management of cardiovascular risk factors<br>* Patient's evaluation of cardiovascular risk factors by the health system<br>Behavioral: A questionnaire on eating behaviors<br>* Assessment of eating behaviors<br>Behavioral: A questionnaire on eating habits to determine consumer profiles<br>* Assessement of eating habit to create a consumer profile<br>Dietary Supplement: A questionnaire on food supplements use<br>* Evaluation od food supplements intake<br>Other: SARS-CoV-2 Infection Questionnaire<br>* SARS-CoV-2 Infection Questionnaire<br>Other: Instantaneous expired air analysis<br>* Carbon monoxyde analysis in expired air<br>Biological: Capillary sampling<br>* Capillary sampling for pollutant analysis (Optional)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indexed left ventricular mass measured by echocardiography |  | Baseline | 
| Left ventricular volume measured by echocardiography |  | Baseline | 
| Tissue doppler imaging e' wave measured by echocardiography |  | Baseline | 
| Ratio E/e' measured by echocardiography |  | Baseline | 
| Left atrial volume measured by echocardiography |  | Baseline | 
| Pulmonary congestion evaluated by lung ultrasound |  | Baseline | 
| Pulse wave velocity measured by Sphygmocor and Complior Analyse |  | Baseline | 
| Carotid intima media thickness measured by echotracking |  | Baseline | 
| Central blood pressure |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the glomerular filtration rate (CKD-EPI formula) | Composite endpoint of degradation of renal function (With outcome 11) | Baseline | 
| Proteinuria (on sample) | Composite endpoint of degradation of renal function (With outcome 10) | Baseline | 
| Blood glucose | Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14) | Baseline | 
| Change in HbA1C | Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14) | Baseline | 
| Change in lipid parameters (LDL and HDL cholesterol) | Composite endpoint of degradation of metabolic parameters (With outcome 12 and 13) | 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 | 
| 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 | 
| Results of future relevant biomarker assays | Biomarkers on the cardiovascular field, measured on biological collection and dependant on the progress of knowledge and technology | Baseline |