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

Overview

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

• 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

Primary outcome measures

• Indexed left ventricular mass measured by echocardiography [Time frame: Baseline]
• Left ventricular volume measured by echocardiography [Time frame: Baseline]
• Tissue doppler imaging e' wave measured by echocardiography [Time frame: Baseline]
• Ratio E/e' measured by echocardiography [Time frame: Baseline]
• Left atrial volume measured by echocardiography [Time frame: Baseline]
• Pulmonary congestion evaluated by lung ultrasound [Time frame: Baseline]
• Pulse wave velocity measured by Sphygmocor and Complior Analyse [Time frame: Baseline]
• Carotid intima media thickness measured by echotracking [Time frame: Baseline]
• Central blood pressure [Time frame: Baseline]

Secondary outcome measures (8)

• Estimation of the glomerular filtration rate (CKD-EPI formula) [Time frame: Baseline]
• Proteinuria (on sample) [Time frame: Baseline]
• Blood glucose [Time frame: Baseline]
• Change in HbA1C [Time frame: Baseline]
• Change in lipid parameters (LDL and HDL cholesterol) [Time frame: 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 [Time frame: 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 [Time frame: Baseline]
• Results of future relevant biomarker assays [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHRU de Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT05916287 · 2020PI129 · 2021-A00449-32

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗