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

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.

Study Overview

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

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

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Vandœuvre-lès-Nancy, Lorraine, France, 54500
      • Recruiting
      • CHRU de Nancy
      • Principal Investigator: Nicolas GIRERD, MD, PhD
      • Contact: Nicolas Girerd, MD, PhD; Phone Number: +333 83 15 73 22; Email: n.girerd@chru-nancy.fr
      • Sub-Investigator: Jean Marc BOIVIN, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy volonteer

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Central blood pressure	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of the glomerular filtration rate (CKD-EPI formula)	Composite endpoint of degradation of renal function (With outcome 11)	Baseline
Proteinuria (on sample)	Composite endpoint of degradation of renal function (With outcome 10)	Baseline
Blood glucose	Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14)	Baseline
Change in HbA1C	Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14)	Baseline
Change in lipid parameters (LDL and HDL cholesterol)	Composite endpoint of degradation of metabolic parameters (With outcome 12 and 13)	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		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	Biomarkers on the cardiovascular field, measured on biological collection and dependant on the progress of knowledge and technology	Baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Nicolas Girerd, MD, PhD, Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 13, 2027
• Study Completion (Estimated): July 13, 2027

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Antihypertensive Agents
• Other Study ID Numbers: 2020PI129; 2021-A00449-32 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No