NCT05916287

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Cardiovascular Diseases
• Cohort Studies
• Genotype
• Risk Factors
• Nutrition

Interventions

Type	Name	Description
BIOLOGICAL	Blood and urine samples	Blood and urine samples
GENETIC	Blood samples	Blood samples
OTHER	Cardiovascular assessment	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).
BEHAVIORAL	Dietary intake	Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire
OTHER	Anthropometric parameters	Measurement of height, weight, abdominal circumference, hip circumference, arm circumference
OTHER	Hemodynamic parameters	Systolic pressure index measurement
OTHER	Hemodynamic parameters	Heart rate measurements, blood pressure measurements, orthostatic BP measurements
OTHER	Hemodynamic parameters	Blood pressure measurements by "unattended BP" monitor over 5 min
OTHER	Hemodynamic parameters	Electrocardiogram
BEHAVIORAL	Assessment of compliance with antihypertensive treatments for treated participants	EVALOBS scale and compliance questionnaire
OTHER	Ambulatory 24 hours measurment of blood pressure	For the first 100 patients willing to participate
BIOLOGICAL	24 hours urinary collection	For the first 100 patients willing to participate. For biobank constitution and measurement of microalbuminuria, creatininuria, osmolarity, natriuresis, kaliuresis, urea, proteinuria and urine dipstick
OTHER	General questionnaires	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...)
OTHER	Women specific questionnaire	Women specific questionnaire
BEHAVIORAL	Women specific questionnaire	Women specific questionnaire
DIAGNOSTIC_TEST	NYHA dyspnea questionnaire	Determination of NYHA class.
BEHAVIORAL	Anxiety questionnaire	Assessment of anxiety
BEHAVIORAL	Epworth Sleepiness Scale	sleep quality assessment
OTHER	A questionnaire on the "perception of the management of cardiovascular risk factors"	Patient's evaluation of cardiovascular risk factors by the health system
BEHAVIORAL	A questionnaire on eating behaviors	Assessment of eating behaviors
BEHAVIORAL	A questionnaire on eating habits to determine consumer profiles	Assessement of eating habit to create a consumer profile
DIETARY_SUPPLEMENT	A questionnaire on food supplements use	Evaluation od food supplements intake
OTHER	SARS-CoV-2 Infection Questionnaire	SARS-CoV-2 Infection Questionnaire
OTHER	Instantaneous expired air analysis	Carbon monoxyde analysis in expired air
BIOLOGICAL	Capillary sampling	Capillary sampling for pollutant analysis (Optional)

Timeline

• Start date: 2023-07-13
• Primary completion: 2027-07-13
• Completion: 2027-07-13
• First posted: 2023-06-23
• Last updated: 2023-08-15

Locations

1 site across 1 country: France