Cardiovascular Diseases, Cohort Studies, Genotype, Risk Factors, Nutrition
Conditions
Brief 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
Interventions
Systolic pressure index measurement
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).
BEHAVIORALDietary intake
Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire
BIOLOGICALBlood and urine samples
Blood and urine samples
GENETICBlood samples
Blood samples
OTHERAnthropometric parameters
Measurement of height, weight, abdominal circumference, hip circumference, arm circumference
BEHAVIORALAssessment of compliance with antihypertensive treatments for treated participants
EVALOBS scale and compliance questionnaire
OTHERAmbulatory 24 hours measurment of blood pressure
For the first 100 patients willing to participate
BIOLOGICAL24 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
OTHERGeneral 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...)
OTHERWomen specific questionnaire
Women specific questionnaire
DIAGNOSTIC_TESTNYHA dyspnea questionnaire
Determination of NYHA class.
BEHAVIORALAnxiety questionnaire
Assessment of anxiety
BEHAVIORALEpworth Sleepiness Scale
sleep quality assessment
OTHERA questionnaire on the perception of the management of cardiovascular risk factors
Patient's evaluation of cardiovascular risk factors by the health system
BEHAVIORALA questionnaire on eating behaviors
Assessment of eating behaviors
BEHAVIORALA questionnaire on eating habits to determine consumer profiles
Assessement of eating habit to create a consumer profile
DIETARY_SUPPLEMENTA questionnaire on food supplements use
Evaluation od food supplements intake
OTHERSARS-CoV-2 Infection Questionnaire
SARS-CoV-2 Infection Questionnaire
OTHERInstantaneous expired air analysis
Carbon monoxyde analysis in expired air
BIOLOGICALCapillary sampling
Capillary sampling for pollutant analysis (Optional)
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central blood pressure | Baseline |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteinuria (on sample) | Baseline | Composite endpoint of degradation of renal function (With outcome 10) |
| Blood glucose | Baseline | Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14) |
| Change in HbA1C | Baseline | Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14) |
| Change in lipid parameters (LDL and HDL cholesterol) | Baseline | Composite endpoint of degradation of metabolic parameters (With outcome 12 and 13) |
| 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 | Baseline | Biomarkers on the cardiovascular field, measured on biological collection and dependant on the progress of knowledge and technology |
| Estimation of the glomerular filtration rate (CKD-EPI formula) | Baseline | Composite endpoint of degradation of renal function (With outcome 11) |
Countries
France
Outcome results
None listed