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

Not Applicable

Recruiting

• Conditions: Risk Factors; Cohort Studies; Cardiovascular Diseases; Genotype; Nutrition
• Interventions: Biological: Blood and urine samples; Genetic: Blood samples; Other: Cardiovascular assessment; Behavioral: Dietary intake; Other: Anthropometric 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; 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

• Registration Number: NCT05916287
• Lead Sponsor: Central Hospital, Nancy, France

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

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Study Start: 2023-07-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-15
• Primary Completion: 2027-07-13
• Study Completion: 2027-07-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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)
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
Estimation of the glomerular filtration rate (CKD-EPI formula)	Baseline	Composite endpoint of degradation of renal function (With outcome 11)
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

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, Lorraine, France