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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Genotype; Nutrition; Risk Factors; Cohort Studies; Cardiovascular Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05916287

2021-A00449-32 (Other Identifier)

2020PI129

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Healthy volonteer

Experimental group

Treatment:

Behavioral: Anxiety questionnaire

Other: Anthropometric parameters

Other: Hemodynamic parameters

Behavioral: Women specific questionnaire

Other: Hemodynamic parameters

Genetic: Blood samples

Biological: Blood and urine samples

Other: Cardiovascular assessment

Behavioral: Dietary intake

Dietary Supplement: A questionnaire on food supplements use

Behavioral: Women specific questionnaire

Other: General questionnaires

Other: Ambulatory 24 hours measurment of blood pressure

Biological: 24 hours urinary collection

Diagnostic Test: NYHA dyspnea questionnaire

Behavioral: A questionnaire on eating habits to determine consumer profiles

Other: Instantaneous expired air analysis

Behavioral: A questionnaire on eating behaviors

Behavioral: Epworth Sleepiness Scale

Other: Hemodynamic parameters

Other: Hemodynamic parameters

Biological: Capillary sampling

Other: SARS-CoV-2 Infection Questionnaire

Other: A questionnaire on the "perception of the management of cardiovascular risk factors"

Behavioral: Assessment of compliance with antihypertensive treatments for treated participants