Clinical trial

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

Name

2020PI129

Description

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.

Trial arms

Trial start

2023-07-13

Estimated PCD

2027-07-13

Trial end

2027-07-13

Status

Recruiting

Treatment

Blood and urine samples

Arms:

Healthy volonteer

Blood samples

Arms:

Healthy volonteer

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).

Arms:

Healthy volonteer

Dietary intake

Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire

Arms:

Healthy volonteer

Anthropometric parameters

Measurement of height, weight, abdominal circumference, hip circumference, arm circumference

Arms:

Healthy volonteer

Hemodynamic parameters

Systolic pressure index measurement

Arms:

Healthy volonteer

Hemodynamic parameters

Heart rate measurements, blood pressure measurements, orthostatic BP measurements

Arms:

Healthy volonteer

Hemodynamic parameters

Blood pressure measurements by "unattended BP" monitor over 5 min

Arms:

Healthy volonteer

Hemodynamic parameters

Electrocardiogram

Arms:

Healthy volonteer

Assessment of compliance with antihypertensive treatments for treated participants

EVALOBS scale and compliance questionnaire

Arms:

Healthy volonteer

Ambulatory 24 hours measurment of blood pressure

For the first 100 patients willing to participate

Arms:

Healthy volonteer

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

Arms:

Healthy volonteer

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...)

Arms:

Healthy volonteer

Women specific questionnaire

Arms:

Healthy volonteer

Women specific questionnaire

Arms:

Healthy volonteer

NYHA dyspnea questionnaire

Determination of NYHA class.

Arms:

Healthy volonteer

Anxiety questionnaire

Assessment of anxiety

Arms:

Healthy volonteer

Epworth Sleepiness Scale

sleep quality assessment

Arms:

Healthy volonteer

A questionnaire on the "perception of the management of cardiovascular risk factors"

Patient's evaluation of cardiovascular risk factors by the health system

Arms:

Healthy volonteer

A questionnaire on eating behaviors

Assessment of eating behaviors

Arms:

Healthy volonteer

A questionnaire on eating habits to determine consumer profiles

Assessement of eating habit to create a consumer profile

Arms:

Healthy volonteer

A questionnaire on food supplements use

Evaluation od food supplements intake

Arms:

Healthy volonteer

SARS-CoV-2 Infection Questionnaire

Arms:

Healthy volonteer

Instantaneous expired air analysis

Carbon monoxyde analysis in expired air

Arms:

Healthy volonteer

Capillary sampling

Capillary sampling for pollutant analysis (Optional)

Arms:

Healthy volonteer

Size

3000

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3000, 'type': 'ESTIMATED'}}

Updated at

2023-08-15

1 organization

Organization

Central Hospital