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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Биопрепарат Blood and urine samples
  Blood and urine samples
• Генная терапия Blood samples
  Blood samples
• Другое 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).
• Поведенческое Dietary intake
  Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire
• Другое Anthropometric parameters
  Measurement of height, weight, abdominal circumference, hip circumference, arm circumference
• Другое Hemodynamic parameters
  Systolic pressure index measurement
• Другое Hemodynamic parameters
  Heart rate measurements, blood pressure measurements, orthostatic BP measurements
• Другое Hemodynamic parameters
  Blood pressure measurements by "unattended BP" monitor over 5 min
• Другое Hemodynamic parameters
  Electrocardiogram
• Поведенческое Assessment of compliance with antihypertensive treatments for treated participants
  EVALOBS scale and compliance questionnaire

Первичные конечные точки

• Indexed left ventricular mass measured by echocardiography [Срок оценки: Baseline]
• Left ventricular volume measured by echocardiography [Срок оценки: Baseline]
• Tissue doppler imaging e' wave measured by echocardiography [Срок оценки: Baseline]
• Ratio E/e' measured by echocardiography [Срок оценки: Baseline]
• Left atrial volume measured by echocardiography [Срок оценки: Baseline]
• Pulmonary congestion evaluated by lung ultrasound [Срок оценки: Baseline]
• Pulse wave velocity measured by Sphygmocor and Complior Analyse [Срок оценки: Baseline]
• Carotid intima media thickness measured by echotracking [Срок оценки: Baseline]
• Central blood pressure [Срок оценки: Baseline]

Вторичные конечные точки (8)

• Estimation of the glomerular filtration rate (CKD-EPI formula) [Срок оценки: Baseline]
• Proteinuria (on sample) [Срок оценки: Baseline]
• Blood glucose [Срок оценки: Baseline]
• Change in HbA1C [Срок оценки: Baseline]
• Change in lipid parameters (LDL and HDL cholesterol) [Срок оценки: Baseline]
• 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 [Срок оценки: 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 [Срок оценки: Baseline]
• Results of future relevant biomarker assays [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHRU de Nancy — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT05916287 · 2020PI129 · 2021-A00449-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗