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- 4th Visit at 17 Years of Cohort STANISLAS - Stanislas Ancillary Study ESCIF (STANISLASV4)

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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
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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).


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4006 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
family
each family, composed of 4 characters at least, is studied
Biological: blood and urine samples
58 ml of blood 120 ml of urine
Other Names:
  • biological analyses
  • biological collection

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



Primary Outcome Measures :
  1. 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

  2. ESCIF ancillary study : pair-wise comparison of functional indices measured in MRI and echocardiography [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. ESCIF ancillary study : inter-observer reproducibility of each method (MRI and Echocardiography) [ Time Frame: day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient having taken part in the STANISLAS troop,
  • At least 18 years old,
  • Written and signed enlightened assent,
  • Ensured social

Exclusion Criteria:

  • Patient unable to understand the informed consent,
  • patient under legal protection

STANISLAS ancillary study:

Study population = subgroup of 76 subjects from the Stanislas cohort

Eligibility:

being member of the Stanislas cohort and participating to 4th visit Specific written and signed enlightened consent for the ESCIF study

Exclusion:

contraindications for MRI examination, possibility of pregnancy


Information from the National Library of Medicine

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


Contacts
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Contact: Patrick ROSSIGNOL 3 15 73 20 ext +33 p.rossignol@chu-nancy.fr
Contact: Sophie LAURENT 3 15 73 13 ext +33 s.laurent@chu-nancy.fr

Locations
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France
Centre d'Investigation Clinique -Plurithématique Recruiting
Nancy, France, 54500
Contact: Faiez ZANNAD, MD,PhD    3 83 15 73 22 ext +33    f.zannad@chu-nancy.fr   
Contact: Patrick ROSSIGNOL, MD,PhD    3 83 15 73 20 ext +33    p.rossignol@chu-nancy.fr   
Principal Investigator: Faiez ZANNAD, MD, PhD         
Centre d'Investigation Clinique- INNOVATIONS TECHNOLOGIQUES Completed
Nancy, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Faiez ZANNAD, PU, PH CHU Nancy, CIC-P, INSERM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01391442     History of Changes
Other Study ID Numbers: 2010-A01469-30
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Keywords provided by Central Hospital, Nancy, France:
follow up of troop,
MRI, Echocardiography, Functional indices
Additional relevant MeSH terms:
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Cardiovascular Diseases