Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01391442 |
| Other study ID # |
2010-A01469-30 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2011 |
| Est. completion date |
July 2016 |
Study information
| Verified date |
February 2024 |
| Source |
Central Hospital, Nancy, France |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Stanislas Cohort is a monocentric familial longitudinal cohort comprised of 1006 families
(4295 subjects) from the Nancy region recruited in 1993-1995 at the Centre for Preventive
Medicine (Centre de Médecine Préventive, CMP), Vandoeuvre lès Nancy for a 5-year periodic
health examination, under the auspices of the Caisse Nationale d'Assurance Maladie (CNAM).
This cohort was established with the primary objective of investigating gene-gene and
gene-environment interactions in the field of cardiovascular diseases, based on the study of
inter-individual variability and familial segregation analysis of biological and
morphological intermediate phenotypes of cardiovascular risk. The longitudinal nature of this
study should enable to take into account the evolution of intermediate phenotypes related to
genetic factors throughout the follow-up period. The families, consisting of two parents and
at least two biological children, were deemed healthy, free of declared acute and/or chronic
illness, in order to assess the effect of genetics on the variability of intermediate
phenotypes studied under physiological conditions (without the influence, in the absence) of
pathology.
The Stanislas Cohort is, both nationally and internationally, the only longitudinal familial
cohort of supposedly healthy subjects on such a large scale.
Brief summary of ancillary study "Cardiac Functional Indices Comparison Between MRI and
Echocardiography" : the ESCIF study is an ancillary study of the Stanislas cohort aiming at
comparing in a cohort of supposedly healthy subjects different cardiac functional indices
between two different modalities : Echocardiography and MRI. Indeed, new cardiac functional
indices have been recently developed in the scope of echocardiography and would be very
useful in MRI. In echography they are computed either from tissue Doppler imaging or from a
specific image analysis called speckle tracking. These two techniques are accessible in MRI
with the Generalized Reconstruction by Inversion of Coupled Systems (GRICS) technology which
provides a motion model from which strains and strain rates may be derived and which allow
longer acquisition without the constraint of breath holding (mandatory to reach high temporal
resolution).
Description:
MAIN STUDY Follow-up visit No. 4 is currently being scheduled, and is planned between 2011
and 2016.
Objectives:
- Conduct a fourth visit, in 2011-2016, enabling a follow-up at 17 years of the cohort
population.
- Enrich the sample collection with new biobanks and clinical phenotyping of the cohort by
conducting selected specific investigations and supported by specific scientific
hypotheses and protocols
- Evaluate the long-term (follow-up, monitoring) of clinical, biological, morphological
data by analyzing:
- The influence of aging (average age of parents in 1993: 45 years and in 2010-2012:
62 years).
- The incidence and changes in prevalence of cardiovascular risk factors comprising
the metabolic syndrome (MS), and their familial segregation, since as early as the
second visit, in some one hundred families, at least one family member presented a
MS according the definition of the NCEP-ATPIII. Approximately 20% of adults had
high blood pressure (hypertension), and 50% had a body mass index above 25 kg/m2.
- The genetic and environmental determinants, through a multifaceted approach
including familial segregation and candidate genes, the progression of
cardiovascular risk and the incidence of cardiovascular diseases (vascular and
coronary diseases, heart failure).
Methodology, Organization:
All Cohort members will be contacted to participate in this fourth visit. The data collected
will be identical to those collected during the previous visits. However, they will be
enriched with new clinical phenotyping conducted at the CIC (principal investigator Prof.
Zannad): collection of blood and urine samples (DNA, RNA, lymphocytic extracts, plasma
biobank, urology biobank), and morphological investigations (electrocardiogram,
echocardiography, carotid echotracking, arterial stiffness, systolic pressure index,
abdominal aortic ultrasound). Based on previous participation rates, the recruitment of 2,000
participants (500 families) is possible.
Expected Results:
This reconvening, for the follow-up at 17 years of the Stanislas Cohort, unique in its
familial nature and having already contributed in a very significant manner in terms of
knowledge generated, will enable in addition to the long-term continuation of its initial
objectives (gene-environment interactions and cardiovascular diseases : Sophie
Visvikis-Siest) to identify more specifically the natural history of the evolution of
cardiovascular risk factors, including metabolic syndrome and its components as well as the
incidence and transition mechanisms toward common cardiovascular diseases, notably vascular
and coronary diseases and heart failure.
ANCILLARY STUDY
Detailed description of the ESCIF ancillary study - Dr. BONNEMAINS :
Objectives :
- to compare cardiac functional indices measured in MRI with the GRICS technique with
equivalent indices measured with echocardiography.
- to assess inter-observer reproducibility of echography and MRI.
Organization :
76 subjects from the Stanislas cohort will be included prospectively in two groups according
to the echocardiographic strains and tissue Doppler velocities acquired during
echocardiography : 38 subjects with normal indices, and 38 with altered indices. Each subject
will be proposed an MRI examination with the GRICS technique the same day to assess the same
indices.
Study design = interventional: MRI. Prospective Number of groups: 2 Enrollment: 76 Last
inclusion in the ESCIF study : 23/09/2014
SUBSTUDY : PHRC I 2013 - BioSe-PreIC - Dr HUTTIN : diagnostic performance of circulating
biomarkers in early screening of heart failure Design : non interventionnal study
Main objective : Determine the contribution, in addition (ontop of ) of the subject's
clinical characteristics, of circulating biomarkers assays (Gal-3, PIIINP, ST2) in a general
population to screen early stages of heart failure (Stage B: asymptomatic patients with
structural abnormalities) validated by trans-thoracic echocardiography (diastolic function
and left ventricular mass)
Inclusion crieria :
Subjects participating to the 4th visit of the STANISLAS cohort
Subjets over 40 years old
Non-inclusion criteria :
Blood sample or echocardiography unavailable
Known cardiopathy
Modarate to severe sympptoms linked to heart failure
Présence of an abnormal diastolic function (E/Ea ratio above 8) and/or left ventricular
hypertrophy (left ventricular mass above 125 g/m² for men and 110 g/m² for women).
