FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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The components of metabolic syndrome (MS),
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Genetic determinants, through an approach of family segregation and candidate genes,
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Multi-omic biomarkers analyzed from the biological collection of the first assessments of the cohort
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Food intake, nutrition and eating behavior
The secondary objectives are
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Identify the factors associated with a degradation of renal parameters (renal function and proteinuria).
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Identify the factors associated with a degradation of metabolic parameters.
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To assess the association between SARS-CoV-2 infection (questionnaire and serological approach) and cardiovascular and renal parameters
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Identify factors associated with the occurrence of clinical cardiovascular events.
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Association between Covid 19 events and general disabling symptoms
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Complete the cohort's biological collection for future biomarker assays related to previous objectives
Study Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- 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
- Estimation of the glomerular filtration rate (CKD-EPI formula) [Baseline]
Composite endpoint of degradation of renal function (With outcome 11)
- 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)
- 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]
- 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 [Baseline]
Biomarkers on the cardiovascular field, measured on biological collection and dependant on the progress of knowledge and technology
Eligibility Criteria
Criteria
Inclusion Criteria:
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aged over 18
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Person who participated in the Stanislas Cohort
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Person affiliated to a social security scheme or beneficiary of such a scheme
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Person having received complete information on the organization of the research and having signed an informed consent
Exclusion Criteria:
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Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1
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Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health
Code:
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Pregnant woman, parturient or nursing mother
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Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
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Person of full age unable to express consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rossignol | Vandœuvre-lès-Nancy | Lorraine | France | 54500 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: Nicolas Girerd, MD, PhD, Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020PI129
- 2021-A00449-32