Cardiovascular DiseasesNCT05916287
FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort
A study testing Blood and urine samples, Blood samples and Cardiovascular assessment in people with Cardiovascular Diseases and Cohort Studies, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cohort Studies, Genotype
- What is being tested?
- Blood and urine samples, Blood samples and Cardiovascular assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2023to 13 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500
Nicolas Girerd, MD, PhD, +333 83 15 73 22, n.girerd@chru-nancy.fr
Nicolas GIRERD, MD, PhD
About this study
Official title: HÉRITABILITÉ FAMILIALE, INTERACTIONS GÈNE-GÈNE ET GÈNE-ENVIRONNEMENT DANS LE DOMAINE DES MALADIES CARDIOVASCULAIRES ET RENALES. Cinquième Visite de la Cohorte STANISLAS
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.
Read the detailed description
The main objective of the STANISLAS cohort is to identify the factors associated with cardiovascular aging (assessed through the study of the degradation of morphological and functional parameters of the heart and vascular systems).
Data (clinical, biological, morphological, genetic and lifestyle) from previous visits (the first having been initiated in the mid-1990s) will be considered as exposure and / or adjustment variables.
The exposure variables of interest will be:
- The components of metabolic syndrome (MS),
- Genetic determinants, through an approach of family segregation and candidate genes,
- Multi-omic biomarkers analyzed from the biological collection of the first assessments of the cohort
- Food intake, nutrition and eating behavior
The secondary objectives are
- Identify the factors associated with a degradation of renal parameters (renal function and proteinuria).
- Identify the factors associated with a degradation of metabolic parameters.
- To assess the association between SARS-CoV-2 infection (questionnaire and serological approach) and cardiovascular and renal parameters
- Identify factors associated with the occurrence of clinical cardiovascular events.
- Association between Covid 19 events and general disabling symptoms
- Complete the cohort's biological collection for future biomarker assays related to previous objectives
- Conditions
- Cardiovascular Diseases, Cohort Studies, Genotype, Risk Factors, Nutrition
- Being tested
- Blood and urine samples, Blood samples, Cardiovascular assessment, Dietary intake, Anthropometric parameters
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samplesBiological
Blood and urine samples
Blood samplesGenetic
Blood samples
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).
Dietary intakeBehavioural
Food frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire
Anthropometric parametersOther
Measurement of height, weight, abdominal circumference, hip circumference, arm circumference
Hemodynamic parametersOther
Systolic pressure index measurement
Hemodynamic parametersOther
Heart rate measurements, blood pressure measurements, orthostatic BP measurements
Hemodynamic parametersOther
Blood pressure measurements by "unattended BP" monitor over 5 min
Hemodynamic parametersOther
Electrocardiogram
Assessment of compliance with antihypertensive treatments for treated participantsBehavioural
EVALOBS scale and compliance questionnaire
Ambulatory 24 hours measurment of blood pressureOther
For the first 100 patients willing to participate
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
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...)
Women specific questionnaireOther
Women specific questionnaire
Women specific questionnaireBehavioural
Women specific questionnaire
NYHA dyspnea questionnaireDiagnostic test
Determination of NYHA class.
Anxiety questionnaireBehavioural
Assessment of anxiety
Epworth Sleepiness ScaleBehavioural
sleep quality assessment
A questionnaire on the "perception of the management of cardiovascular risk factors"Other
Patient's evaluation of cardiovascular risk factors by the health system
A questionnaire on eating behaviorsBehavioural
Assessment of eating behaviors
A questionnaire on eating habits to determine consumer profilesBehavioural
Assessement of eating habit to create a consumer profile
A questionnaire on food supplements useDietary supplement
Evaluation od food supplements intake
SARS-CoV-2 Infection QuestionnaireOther
SARS-CoV-2 Infection Questionnaire
Instantaneous expired air analysisOther
Carbon monoxyde analysis in expired air
Capillary samplingBiological
Capillary sampling for pollutant analysis (Optional)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volonteer | Experimental | Not described Receives: Biological: Blood and urine samples; Genetic: Blood samples; Other: Cardiovascular assessment; Behavioral: Dietary intake; Other: Anthropometric parameters; Other: Hemodynamic parameters; Behavioral: Assessment of compliance with antihypertensive treatments for treated participants; Other: Ambulatory 24 hours measurment of blood pressure; Biological: 24 hours urinary collection; Other: General questionnaires; Other: Women specific questionnaire; Behavioral: Women specific questionnaire; Diagnostic Test: NYHA dyspnea questionnaire; Behavioral: Anxiety questionnaire; Behavioral: Epworth Sleepiness Scale; Other: A questionnaire on the "perception of the management of cardiovascular risk factors"; Behavioral: A questionnaire on eating behaviors; Behavioral: A questionnaire on eating habits to determine consumer profiles; Dietary Supplement: A questionnaire on food supplements use; Other: SARS-CoV-2 Infection Questionnaire; Other: Instantaneous expired air analysis; Biological: Capillary sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indexed left ventricular mass measured by echocardiography
Measured: Baseline
Left ventricular volume measured by echocardiography
Measured: Baseline
Tissue doppler imaging e' wave measured by echocardiography
Measured: Baseline
Ratio E/e' measured by echocardiography
Measured: Baseline
Left atrial volume measured by echocardiography
Measured: Baseline
Pulmonary congestion evaluated by lung ultrasound
Measured: Baseline
Pulse wave velocity measured by Sphygmocor and Complior Analyse
Measured: Baseline
Carotid intima media thickness measured by echotracking
Measured: Baseline
Central blood pressure
Measured: Baseline
Secondary outcomes (8)
Estimation of the glomerular filtration rate (CKD-EPI formula)
Composite endpoint of degradation of renal function (With outcome 11)
Measured: Baseline
Proteinuria (on sample)
Composite endpoint of degradation of renal function (With outcome 10)
Measured: Baseline
Blood glucose
Composite endpoint of degradation of metabolic parameters (With outcome 13 and 14)
Measured: Baseline
Change in HbA1C
Composite endpoint of degradation of metabolic parameters (With outcome 12 and 14)
Measured: Baseline
Change in lipid parameters (LDL and HDL cholesterol)
Composite endpoint of degradation of metabolic parameters (With outcome 12 and 13)
Measured: Baseline
Occurrence of the following clinical CV events: Hospitalization for HF, HF not requiring hospitalization, Atrial fibrillation, Acute coronary syndrome, Coronary artery disease, Hypertension (requiring introduction of drug treatment), Stroke
Measured: Baseline
General symptoms persisting beyond 8 weeks after SARS-CoV-2 infection such as: disabling asthenia, disabling dyspnea, cardiothoracic signs, arthromyalgia, neurocognitive disorders or anosmia
Measured: Baseline
Results of future relevant biomarker assays
Biomarkers on the cardiovascular field, measured on biological collection and dependant on the progress of knowledge and technology
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start13 Jul 2023
- Primary completion13 Jul 2027 (estimated)
- Study completion13 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas Girerd, MD, PhD, Principal investigator, Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916287
- Sponsor's protocol ID
- 2020PI129
- Other IDs
- 2021-A00449-32
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HÉRITABILITÉ FAMILIALE, INTERACTIONS GÈNE-GÈNE ET GÈNE-ENVIRONNEMENT DANS LE DOMAINE DES MALADIES CARDIOVASCULAIRES ET RENALES. Cinquième Visite de la Cohorte STANISLAS
- ClinicalTrials.gov ID
- NCT05916287
- Acronym / sponsor ID
- 2020PI129
- Conditions
- Cardiovascular Diseases, Cohort Studies, Genotype, Risk Factors, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Jul 2027 (estimated)
- Study completion
- 13 Jul 2027 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective of the STANISLAS cohort is to identify the factors associated with cardiovascular aging (assessed through the study of the degradation of morphological and functional parameters of the heart and vascular systems).
Data (clinical, biological, morphological, genetic and lifestyle) from previous visits (the first having been initiated in the mid-1990s) will be considered as exposure and / or adjustment variables.
The exposure variables of interest will be:
- The components of metabolic syndrome (MS),
- Genetic determinants, through an approach of family segregation and candidate genes,
- Multi-omic biomarkers analyzed from the biological collection of the first assessments of the cohort
- Food intake, nutrition and eating behavior
The secondary objectives are
- Identify the factors associated with a degradation of renal parameters (renal function and proteinuria).
- Identify the factors associated with a degradation of metabolic parameters.
- To assess the association between SARS-CoV-2 infection (questionnaire and serological approach) and cardiovascular and renal parameters
- Identify factors associated with the occurrence of clinical cardiovascular events.
- Association between Covid 19 events and general disabling symptoms
- Complete the cohort's biological collection for future biomarker assays related to previous objectives
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volonteer | Experimental | Biological: Blood and urine samples, Genetic: Blood samples, Other: Cardiovascular assessment, Behavioral: Dietary intake, Other: Anthropometric parameters, Other: Hemodynamic parameters, Behavioral: Assessment of compliance with antihypertensive treatments for treated participants, Other: Ambulatory 24 hours measurment of blood pressure, Biological: 24 hours urinary collection, Other: General questionnaires, Other: Women specific questionnaire, Behavioral: Women specific questionnaire, Diagnostic Test: NYHA dyspnea questionnaire, Behavioral: Anxiety questionnaire, Behavioral: Epworth Sleepiness Scale, Other: A questionnaire on the "perception of the management of cardiovascular risk factors", Behavioral: A questionnaire on eating behaviors, Behavioral: A questionnaire on eating habits to determine consumer profiles, Dietary Supplement: A questionnaire on food supplements use, Other: SARS-CoV-2 Infection Questionnaire, Other: Instantaneous expired air analysis, Biological: Capillary sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine samplesBlood and urine samples | Biological | Healthy volonteer |
| Blood samplesBlood samples | Genetic | Healthy volonteer |
| Cardiovascular assessmentEchocardiography, 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). | Other | Healthy volonteer |
| Dietary intakeFood frequency questionnaires, ''Dutch eating behaviour questionnaire'' and dietary supplement questionnaire | Behavioural | Healthy volonteer |
| Anthropometric parametersMeasurement of height, weight, abdominal circumference, hip circumference, arm circumference | Other | Healthy volonteer |
| Hemodynamic parametersSystolic pressure index measurement | Other | Healthy volonteer |
| Hemodynamic parametersHeart rate measurements, blood pressure measurements, orthostatic BP measurements | Other | Healthy volonteer |
| Hemodynamic parametersBlood pressure measurements by "unattended BP" monitor over 5 min | Other | Healthy volonteer |
| Hemodynamic parametersElectrocardiogram | Other | Healthy volonteer |
| Assessment of compliance with antihypertensive treatments for treated participantsEVALOBS scale and compliance questionnaire | Behavioural | Healthy volonteer |
| Ambulatory 24 hours measurment of blood pressureFor the first 100 patients willing to participate | Other | Healthy volonteer |
| 24 hours urinary collectionFor the first 100 patients willing to participate. For biobank constitution and measurement of microalbuminuria, creatininuria, osmolarity, natriuresis, kaliuresis, urea, proteinuria and urine dipstick | Biological | Healthy volonteer |
| General questionnairesCollection 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...) | Other | Healthy volonteer |
| Women specific questionnaireWomen specific questionnaire | Other | Healthy volonteer |
| Women specific questionnaireWomen specific questionnaire | Behavioural | Healthy volonteer |
| NYHA dyspnea questionnaireDetermination of NYHA class. | Diagnostic test | Healthy volonteer |
| Anxiety questionnaireAssessment of anxiety | Behavioural | Healthy volonteer |
| Epworth Sleepiness Scalesleep quality assessment | Behavioural | Healthy volonteer |
| A questionnaire on the "perception of the management of cardiovascular risk factors"Patient's evaluation of cardiovascular risk factors by the health system | Other | Healthy volonteer |
| A questionnaire on eating behaviorsAssessment of eating behaviors | Behavioural | Healthy volonteer |
| A questionnaire on eating habits to determine consumer profilesAssessement of eating habit to create a consumer profile | Behavioural | Healthy volonteer |
| A questionnaire on food supplements useEvaluation od food supplements intake | Dietary supplement | Healthy volonteer |
| SARS-CoV-2 Infection QuestionnaireSARS-CoV-2 Infection Questionnaire | Other | Healthy volonteer |
| Instantaneous expired air analysisCarbon monoxyde analysis in expired air | Other | Healthy volonteer |
| Capillary samplingCapillary sampling for pollutant analysis (Optional) | Biological | Healthy volonteer |
Primary outcome
Indexed left ventricular mass measured by echocardiography
Time frame: Baseline
Left ventricular volume measured by echocardiography
Time frame: Baseline
Tissue doppler imaging e' wave measured by echocardiography
Time frame: Baseline
Ratio E/e' measured by echocardiography
Time frame: Baseline
Left atrial volume measured by echocardiography
Time frame: Baseline
Pulmonary congestion evaluated by lung ultrasound
Time frame: Baseline
Pulse wave velocity measured by Sphygmocor and Complior Analyse
Time frame: Baseline
Carotid intima media thickness measured by echotracking
Time frame: Baseline
Central blood pressure
Time frame: Baseline
8 secondary outcomes
Estimation of the glomerular filtration rate (CKD-EPI formula)
Time frame: Baseline
Proteinuria (on sample)
Time frame: Baseline
Blood glucose
Time frame: Baseline
Change in HbA1C
Time frame: Baseline
Change in lipid parameters (LDL and HDL cholesterol)
Time frame: Baseline
Occurrence of the following clinical CV events: Hospitalization for HF, HF not requiring hospitalization, Atrial fibrillation, Acute coronary syndrome, Coronary artery disease, Hypertension (requiring introduction of drug treatment), Stroke
Time frame: Baseline
General symptoms persisting beyond 8 weeks after SARS-CoV-2 infection such as: disabling asthenia, disabling dyspnea, cardiothoracic signs, arthromyalgia, neurocognitive disorders or anosmia
Time frame: Baseline
Results of future relevant biomarker assays
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Girerd, MD, PhD principal investigator
Centre d'Investigation Clinique 1433 module Plurithématique - CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and urine samples, Blood samples and Cardiovascular assessment in people with Cardiovascular Diseases and Cohort Studies, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indexed left ventricular mass measured by echocardiography (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.