FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort
NCT ID: NCT05916287
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2023-07-13
2027-07-13
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy volonteer
Blood and urine samples
Blood and urine samples
Blood samples
Blood samples
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).
Dietary intake
Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire
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
Assessment of compliance with antihypertensive treatments for treated participants
EVALOBS scale and compliance questionnaire
Ambulatory 24 hours measurment of blood pressure
For the first 100 patients willing to participate
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
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
Women specific questionnaire
Women specific questionnaire
NYHA dyspnea questionnaire
Determination of NYHA class.
Anxiety questionnaire
Assessment of anxiety
Epworth Sleepiness Scale
sleep quality assessment
A questionnaire on the "perception of the management of cardiovascular risk factors"
Patient's evaluation of cardiovascular risk factors by the health system
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
A questionnaire on food supplements use
Evaluation od food supplements intake
SARS-CoV-2 Infection Questionnaire
SARS-CoV-2 Infection Questionnaire
Instantaneous expired air analysis
Carbon monoxyde analysis in expired air
Capillary sampling
Capillary sampling for pollutant analysis (Optional)
Interventions
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Blood and urine samples
Blood and urine samples
Blood samples
Blood samples
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).
Dietary intake
Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire
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
Assessment of compliance with antihypertensive treatments for treated participants
EVALOBS scale and compliance questionnaire
Ambulatory 24 hours measurment of blood pressure
For the first 100 patients willing to participate
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
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
Women specific questionnaire
Women specific questionnaire
NYHA dyspnea questionnaire
Determination of NYHA class.
Anxiety questionnaire
Assessment of anxiety
Epworth Sleepiness Scale
sleep quality assessment
A questionnaire on the "perception of the management of cardiovascular risk factors"
Patient's evaluation of cardiovascular risk factors by the health system
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
A questionnaire on food supplements use
Evaluation od food supplements intake
SARS-CoV-2 Infection Questionnaire
SARS-CoV-2 Infection Questionnaire
Instantaneous expired air analysis
Carbon monoxyde analysis in expired air
Capillary sampling
Capillary sampling for pollutant analysis (Optional)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
Yes
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Pr. Nicolas GIRERD
Coordinating doctor
Principal Investigators
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Nicolas Girerd, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy
Locations
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CHRU de Nancy
Vandœuvre-lès-Nancy, Lorraine, France
Countries
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Facility Contacts
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Other Identifiers
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2021-A00449-32
Identifier Type: OTHER
Identifier Source: secondary_id
2020PI129
Identifier Type: -
Identifier Source: org_study_id
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