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

Cardiovascular Diseases Clinical Trial

Official title:

HÉRITABILITÉ FAMILIALE, INTERACTIONS GÈNE-GÈNE ET GÈNE-ENVIRONNEMENT DANS LE DOMAINE DES MALADIES CARDIOVASCULAIRES ET RENALES. Cinquième Visite de la Cohorte STANISLAS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916287
• Other study ID #: 2020PI129
• Secondary ID: 2021-A00449-32
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: July 13, 2027

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 13, 2027
• Est. primary completion date: July 13, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cohort Studies
• Genotype
• Nutrition
• Risk Factors

Intervention

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
• Hemodynamic parameters
Systolic pressure index measurement
• Hemodynamic parameters
Heart rate measurements, blood pressure measurements, orthostatic BP measurements
• Hemodynamic parameters
Blood pressure measurements by "unattended BP" monitor over 5 min
• 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...)
• 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
• 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
• 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
• Instantaneous expired air analysis
Carbon monoxyde analysis in expired air

Biological:
• Capillary sampling
Capillary sampling for pollutant analysis (Optional)

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandœuvre-lès-Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indexed left ventricular mass measured by echocardiography		Baseline
Primary	Left ventricular volume measured by echocardiography		Baseline
Primary	Tissue doppler imaging e' wave measured by echocardiography		Baseline
Primary	Ratio E/e' measured by echocardiography		Baseline
Primary	Left atrial volume measured by echocardiography		Baseline
Primary	Pulmonary congestion evaluated by lung ultrasound		Baseline
Primary	Pulse wave velocity measured by Sphygmocor and Complior Analyse		Baseline
Primary	Carotid intima media thickness measured by echotracking		Baseline
Primary	Central blood pressure		Baseline
Secondary	Estimation of the glomerular filtration rate (CKD-EPI formula)	Composite endpoint of degradation of renal function (With outcome 11)	Baseline
Secondary	Proteinuria (on sample)	Composite endpoint of degradation of renal function (With outcome 10)	Baseline
Secondary	Blood glucose	Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14)	Baseline
Secondary	Change in HbA1C	Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14)	Baseline
Secondary	Change in lipid parameters (LDL and HDL cholesterol)	Composite endpoint of degradation of metabolic parameters (With outcome 12 and 13)	Baseline
Secondary	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
Secondary	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
Secondary	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