- 4th Visit at 17 Years of Cohort STANISLAS - Stanislas Ancillary Study ESCIF (STANISLASV4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01391442|
Recruitment Status : Unknown
Verified March 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : July 12, 2011
Last Update Posted : March 8, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Biological: blood and urine samples Genetic: blood sample Other: cardiovascular assessment Other: Stanislas ancillary study : MRI examination with GRICS technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4006 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family Heritability, Investigating Gene-gene and Gene-environment Interactions in the Field of Cardiovascular Diseases - 4th VISIT (at 17 Years) of the STANISLAS COHORT|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
each family, composed of 4 characters at least, is studied
Biological: blood and urine samples
58 ml of blood 120 ml of urine
Genetic: blood sample
11 ml of blood
Other Name: ADN and ARN collection
Other: cardiovascular assessment
echography, echodoppler, measure of blood pressure...
Other Name: cardiovascular risk factors
Other: Stanislas ancillary study : MRI examination with GRICS technique
- investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases [ Time Frame: day 1 ]study of inter-individual variability and familial segregation analysis of biological and morphological intermediate phenotypes of cardiovascular risk
- ESCIF ancillary study : pair-wise comparison of functional indices measured in MRI and echocardiography [ Time Frame: day 1 ]
- ESCIF ancillary study : inter-observer reproducibility of each method (MRI and Echocardiography) [ Time Frame: day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391442
|Contact: Patrick ROSSIGNOL||3 15 73 20 ext +firstname.lastname@example.org|
|Contact: Sophie LAURENT||3 15 73 13 ext +email@example.com|
|Centre d'Investigation Clinique -Plurithématique||Recruiting|
|Nancy, France, 54500|
|Contact: Faiez ZANNAD, MD,PhD 3 83 15 73 22 ext +33 firstname.lastname@example.org|
|Contact: Patrick ROSSIGNOL, MD,PhD 3 83 15 73 20 ext +33 email@example.com|
|Principal Investigator: Faiez ZANNAD, MD, PhD|
|Centre d'Investigation Clinique- INNOVATIONS TECHNOLOGIQUES||Completed|
|Nancy, France, 54500|
|Principal Investigator:||Faiez ZANNAD, PU, PH||CHU Nancy, CIC-P, INSERM|