NCT01391442

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,705

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

May 12, 2011

Last Update Submit

March 27, 2024

Conditions

Keywords

follow up of troop,MRI, Echocardiography, Functional indices

Outcome Measures

Primary Outcomes (2)

  • investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases

    study of inter-individual variability and familial segregation analysis of biological and morphological intermediate phenotypes of cardiovascular risk

    day 1

  • ESCIF ancillary study : pair-wise comparison of functional indices measured in MRI and echocardiography

    day 1

Secondary Outcomes (1)

  • ESCIF ancillary study : inter-observer reproducibility of each method (MRI and Echocardiography)

    day 1

Study Arms (1)

family

OTHER

each family, composed of 4 characters at least, is studied

Biological: blood and urine samplesGenetic: blood sampleOther: cardiovascular assessmentOther: Stanislas ancillary study : MRI examination with GRICS technique

Interventions

58 ml of blood 120 ml of urine

Also known as: biological analyses, biological collection
family

11 ml of blood

Also known as: ADN and ARN collection
family

echography, echodoppler, measure of blood pressure...

Also known as: cardiovascular risk factors
family

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • contraindications for MRI examination, possibility of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'Investigation Clinique -Plurithématique

Nancy, 54500, France

Location

Centre d'Investigation Clinique- INNOVATIONS TECHNOLOGIQUES

Nancy, 54500, France

Location

Related Publications (7)

  • Lagrange J, Jahangiri M PhD, Baudry G, Mercier N, Monzo L, Lamiral Z, Duarte K, Ter Maaten JM, Zannad F, Voors AA, Girerd N. Association Between Endothelial Alterations, Cardiac Function, and Outcomes From Health to Heart Failure: Insight From the STANISLAS, MEDIA-DHF, and BIOSTAT-CHF Cohorts. J Am Heart Assoc. 2025 Jun 3;14(11):e040179. doi: 10.1161/JAHA.124.040179. Epub 2025 May 29.

  • Lai TP, Verhulst S, Savage SA, Gadalla SM, Benetos A, Toupance S, Factor-Litvak P, Susser E, Aviv A. Buildup from birth onward of short telomeres in human hematopoietic cells. Aging Cell. 2023 Jun;22(6):e13844. doi: 10.1111/acel.13844. Epub 2023 Apr 28.

  • Kobayashi M, Huttin O, Magnusson M, Ferreira JP, Bozec E, Huby AC, Preud'homme G, Duarte K, Lamiral Z, Dalleau K, Bresso E, Smail-Tabbone M, Devignes MD, Nilsson PM, Leosdottir M, Boivin JM, Zannad F, Rossignol P, Girerd N; STANISLAS Study Investigators. Machine Learning-Derived Echocardiographic Phenotypes Predict Heart Failure Incidence in Asymptomatic Individuals. JACC Cardiovasc Imaging. 2022 Feb;15(2):193-208. doi: 10.1016/j.jcmg.2021.07.004. Epub 2021 Sep 15.

  • Monzo L, Ferreira JP, Lamiral Z, Bozec E, Boivin JM, Huttin O, Lopez-Sublet M, Girerd N, Zannad F, Rossignol P. Isolated diastolic hypertension and target organ damage: Findings from the STANISLAS cohort. Clin Cardiol. 2021 Nov;44(11):1516-1525. doi: 10.1002/clc.23713. Epub 2021 Sep 15.

  • Wagner S, Lioret S, Girerd N, Duarte K, Lamiral Z, Bozec E, Van den Berghe L, Hoge A, Donneau AF, Boivin JM, Merckle L, Zannad F, Laville M, Rossignol P, Nazare JA. Association of Dietary Patterns Derived Using Reduced-Rank Regression With Subclinical Cardiovascular Damage According to Generation and Sex in the STANISLAS Cohort. J Am Heart Assoc. 2020 Apr 7;9(7):e013836. doi: 10.1161/JAHA.119.013836. Epub 2020 Mar 21.

  • Benetos A, Verhulst S, Labat C, Lai TP, Girerd N, Toupance S, Zannad F, Rossignol P, Aviv A. Telomere length tracking in children and their parents: implications for adult onset diseases. FASEB J. 2019 Dec;33(12):14248-14253. doi: 10.1096/fj.201901275R. Epub 2019 Oct 25.

  • Ferreira JP, Girerd N, Bozec E, Machu JL, Boivin JM, London GM, Zannad F, Rossignol P. Intima-Media Thickness Is Linearly and Continuously Associated With Systolic Blood Pressure in a Population-Based Cohort (STANISLAS Cohort Study). J Am Heart Assoc. 2016 Jun 16;5(6):e003529. doi: 10.1161/JAHA.116.003529.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Blood Specimen CollectionBiological Oxygen Demand AnalysisHeart Disease Risk Factors

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesEnvironmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public HealthPublic Health PracticeRisk FactorsRiskProbabilityStatistics as TopicEpidemiologic MethodsCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation Mechanisms

Study Officials

  • Faiez ZANNAD, PU, PH

    CHU Nancy, CIC-P, INSERM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 12, 2011

First Posted

July 12, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 28, 2024

Record last verified: 2024-02

Locations