NCT05916287

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
15mo left

Started Jul 2023

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress70%
Jul 2023Jul 2027

First Submitted

Initial submission to the registry

June 2, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2027

Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

4 years

First QC Date

June 2, 2023

Last Update Submit

August 11, 2023

Conditions

Cardiovascular DiseasesCohort StudiesGenotypeRisk FactorsNutrition

Outcome Measures

Primary Outcomes (9)

  • Indexed left ventricular mass measured by echocardiography

    Baseline

  • Left ventricular volume measured by echocardiography

    Baseline

  • Tissue doppler imaging e' wave measured by echocardiography

    Baseline

  • Ratio E/e' measured by echocardiography

    Baseline

  • Left atrial volume measured by echocardiography

    Baseline

  • Pulmonary congestion evaluated by lung ultrasound

    Baseline

  • Pulse wave velocity measured by Sphygmocor and Complior Analyse

    Baseline

  • Carotid intima media thickness measured by echotracking

    Baseline

  • Central blood pressure

    Baseline

Secondary Outcomes (8)

  • Estimation of the glomerular filtration rate (CKD-EPI formula)

    Baseline

  • Proteinuria (on sample)

    Baseline

  • Blood glucose

    Baseline

  • Change in HbA1C

    Baseline

  • Change in lipid parameters (LDL and HDL cholesterol)

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

Healthy volonteer

EXPERIMENTAL
Biological: Blood and urine samplesGenetic: Blood samplesOther: Cardiovascular assessmentBehavioral: Dietary intakeOther: Anthropometric parametersOther: Hemodynamic parametersBehavioral: Assessment of compliance with antihypertensive treatments for treated participantsOther: Ambulatory 24 hours measurment of blood pressureBiological: 24 hours urinary collectionOther: General questionnairesOther: Women specific questionnaireBehavioral: Women specific questionnaireDiagnostic Test: NYHA dyspnea questionnaireBehavioral: Anxiety questionnaireBehavioral: Epworth Sleepiness ScaleOther: A questionnaire on the "perception of the management of cardiovascular risk factors"Behavioral: A questionnaire on eating behaviorsBehavioral: A questionnaire on eating habits to determine consumer profilesDietary Supplement: A questionnaire on food supplements useOther: SARS-CoV-2 Infection QuestionnaireOther: Instantaneous expired air analysisBiological: Capillary sampling

Interventions

Blood and urine samplesBIOLOGICAL

Blood and urine samples

Healthy volonteer
Blood samplesGENETIC

Blood samples

Healthy volonteer
Cardiovascular assessmentOTHER

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).

Healthy volonteer
Dietary intakeBEHAVIORAL

Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire

Healthy volonteer
Anthropometric parametersOTHER

Measurement of height, weight, abdominal circumference, hip circumference, arm circumference

Healthy volonteer
Hemodynamic parametersOTHER

Systolic pressure index measurement

Healthy volonteer
Assessment of compliance with antihypertensive treatments for treated participantsBEHAVIORAL

EVALOBS scale and compliance questionnaire

Healthy volonteer
Ambulatory 24 hours measurment of blood pressureOTHER

For the first 100 patients willing to participate

Healthy volonteer
24 hours urinary collectionBIOLOGICAL

For the first 100 patients willing to participate. For biobank constitution and measurement of microalbuminuria, creatininuria, osmolarity, natriuresis, kaliuresis, urea, proteinuria and urine dipstick

Healthy volonteer
General questionnairesOTHER

Collection of socio-demographic data such as age, level of education, profession, household income, smoking status, physical activity, perception of health, prematurity, height and weight at birth, family and personal history especially cardiovascular (history of stroke, myocardial infarction, heart failure, current pathologies, drugs, tobacco...)

Healthy volonteer
Women specific questionnaireOTHER

Women specific questionnaire

Healthy volonteer
NYHA dyspnea questionnaireDIAGNOSTIC_TEST

Determination of NYHA class.

Healthy volonteer
Anxiety questionnaireBEHAVIORAL

Assessment of anxiety

Healthy volonteer
Epworth Sleepiness ScaleBEHAVIORAL

sleep quality assessment

Healthy volonteer
A questionnaire on the "perception of the management of cardiovascular risk factors"OTHER

Patient's evaluation of cardiovascular risk factors by the health system

Healthy volonteer
A questionnaire on eating behaviorsBEHAVIORAL

Assessment of eating behaviors

Healthy volonteer
A questionnaire on eating habits to determine consumer profilesBEHAVIORAL

Assessement of eating habit to create a consumer profile

Healthy volonteer
A questionnaire on food supplements useDIETARY_SUPPLEMENT

Evaluation od food supplements intake

Healthy volonteer
SARS-CoV-2 Infection QuestionnaireOTHER

SARS-CoV-2 Infection Questionnaire

Healthy volonteer
Instantaneous expired air analysisOTHER

Carbon monoxyde analysis in expired air

Healthy volonteer
Capillary samplingBIOLOGICAL

Capillary sampling for pollutant analysis (Optional)

Healthy volonteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Blood Specimen CollectionEatingAmbulatory Care Facilities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Nicolas Girerd, MD, PhD

    Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating doctor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 23, 2023

Study Start

July 13, 2023

Primary Completion (Estimated)

July 13, 2027

Study Completion (Estimated)

July 13, 2027

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations

FR(1)