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NCT Number: NCT05916287

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

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.

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Key information

Conditions

Cardiovascular Diseases Cohort Studies Genotype Nutrition Risk Factors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location status: Recruiting

Location contact

Jean Marc BOIVIN, MD, PhD

SUB_INVESTIGATOR

Nicolas GIRERD, MD, PhD

PRINCIPAL_INVESTIGATOR

Nicolas Girerd, MD, PhD

CONTACT

[email protected]

+333 83 15 73 22

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and urine samples

Biological

Blood and urine samples

blood samples

Genetic

Blood samples

Cardiovascular assessment

Other

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

Behavioral

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

Anthropometric parameters

Other

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

Hemodynamic parameters

Other

Systolic pressure index measurement

Assessment of compliance with antihypertensive treatments for treated participants

Behavioral

EVALOBS scale and compliance questionnaire

Ambulatory 24 hours measurment of blood pressure

Other

For the first 100 patients willing to participate

24 hours urinary collection

Biological

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

Other

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

Other

Women specific questionnaire

Women specific questionnaire

Behavioral

Women specific questionnaire

NYHA dyspnea questionnaire

Diagnostic Test

Determination of NYHA class.

Anxiety questionnaire

Behavioral

Assessment of anxiety

Epworth Sleepiness Scale

Behavioral

sleep quality assessment

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

Other

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

A questionnaire on eating behaviors

Behavioral

Assessment of eating behaviors

A questionnaire on eating habits to determine consumer profiles

Behavioral

Assessement of eating habit to create a consumer profile

A questionnaire on food supplements use

Dietary Supplement

Evaluation od food supplements intake

SARS-CoV-2 Infection Questionnaire

Other

SARS-CoV-2 Infection Questionnaire

Instantaneous expired air analysis

Other

Carbon monoxyde analysis in expired air

Capillary sampling

Biological

Capillary sampling for pollutant analysis (Optional)

Primary outcomes

  1. Indexed left ventricular mass measured by echocardiography

    Time frame: Baseline

  2. Left ventricular volume measured by echocardiography

    Time frame: Baseline

  3. Tissue doppler imaging e' wave measured by echocardiography

    Time frame: Baseline

  4. Ratio E/e' measured by echocardiography

    Time frame: Baseline

  5. Left atrial volume measured by echocardiography

    Time frame: Baseline

  6. Pulmonary congestion evaluated by lung ultrasound

    Time frame: Baseline

  7. Pulse wave velocity measured by Sphygmocor and Complior Analyse

    Time frame: Baseline

  8. Carotid intima media thickness measured by echotracking

    Time frame: Baseline

  9. Central blood pressure

    Time frame: Baseline

Secondary outcomes

  1. Estimation of the glomerular filtration rate (CKD-EPI formula)

    Time frame: Baseline

    Composite endpoint of degradation of renal function (With outcome 11)

  2. Proteinuria (on sample)

    Time frame: Baseline

    Composite endpoint of degradation of renal function (With outcome 10)

  3. Blood glucose

    Time frame: Baseline

    Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14)

  4. Change in HbA1C

    Time frame: Baseline

    Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14)

  5. Change in lipid parameters (LDL and HDL cholesterol)

    Time frame: Baseline

    Composite endpoint of degradation of metabolic parameters (With outcome 12 and 13)

  6. 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

    Time frame: Baseline

  7. General symptoms persisting beyond 8 weeks after SARS-CoV-2 infection such as: disabling asthenia, disabling dyspnea, cardiothoracic signs, arthromyalgia, neurocognitive disorders or anosmia

    Time frame: Baseline

  8. Results of future relevant biomarker assays

    Time frame: Baseline

    Biomarkers on the cardiovascular field, measured on biological collection and dependant on the progress of knowledge and technology

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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