Clinical trial NCT05916287: FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort
Official title: HÉRITABILITÉ FAMILIALE, INTERACTIONS GÈNE-GÈNE ET GÈNE-ENVIRONNEMENT DANS LE DOMAINE DES MALADIES CARDIOVASCULAIRES ET RENALES. Cinquième Visite de la Cohorte STANISLAS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Cohort Studies
Genotype
Risk Factors
Nutrition
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Indexed left ventricular mass measured by echocardiography
timeFrame: Baseline
measure: Left ventricular volume measured by echocardiography
timeFrame: Baseline
measure: Tissue doppler imaging e' wave measured by echocardiography
timeFrame: Baseline
measure: Ratio E/e' measured by echocardiography
timeFrame: Baseline
measure: Left atrial volume measured by echocardiography
timeFrame: Baseline
measure: Pulmonary congestion evaluated by lung ultrasound
timeFrame: Baseline
measure: Pulse wave velocity measured by Sphygmocor and Complior Analyse
timeFrame: Baseline
measure: Carotid intima media thickness measured by echotracking
timeFrame: Baseline
measure: Central blood pressure
timeFrame: Baseline
Secondary outcomes:
measure: Estimation of the glomerular filtration rate (CKD-EPI formula)
timeFrame: Baseline
measure: Proteinuria (on sample)
timeFrame: Baseline
measure: Blood glucose
timeFrame: Baseline
measure: Change in HbA1C
timeFrame: Baseline
measure: Change in lipid parameters (LDL and HDL cholesterol)
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: General symptoms persisting beyond 8 weeks after SARS-CoV-2 infection such as: disabling asthenia, disabling dyspnea, cardiothoracic signs, arthromyalgia, neurocognitive disorders or anosmia
timeFrame: Baseline
measure: Results of future relevant biomarker assays
timeFrame: Baseline
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
state: Lorraine
Study officials:
affiliation: Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy
name: Nicolas Girerd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: