Multimodal Cardiovascular and Hepatic Population Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

Medical imaging is increasingly important for understanding diseases, detecting them early, and personalizing treatments. New imaging techniques, which can measure processes in the body without surgery, are opening the door to a more precise approach to medicine. Instead of relying on general probabilities, this technology allows us to analyze specific factors in a person's health, leading to better predictions and targeted treatments. One key challenge in medicine today is reducing "residual individual risk"-the remaining health risks that current treatments don't fully address. This involves understanding how factors like age, sex, genetics, and environment affect our health, particularly when it comes to conditions like heart and liver disease. By using imaging to distinguish between normal aging and disease, we can better assess individual health risks.

The current project will create a large collection of medical images linked with health data from a broad population across France. Using advanced, non-invasive techniques such as MRI and ultrasound, researchers will analyze the heart, blood vessels, and liver in detail, considering factors like gender and health risk profiles. This will help improve our understanding of these diseases, which are often silent and not well understood, providing direct benefits to the participants. Ultimately, the goal is to optimize imaging technologies for large-scale studies, which will help enhance early detection and prevention for everyone.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participation to the Constances cohort

Age ≥ 20 years

No overt cardiovascular or hepatic disease or related symptoms

No known family or personal genetic disease

Disqualifiers

Renal function impairment with GFR < 60 mL/min/1.73m2

Deprived of liberty or persons subject to a legal protection measure (under guardianship or trusteeship)

People with contraindications to MRI (claustrophobia, presence of metallic elements…)

Pregnant or breastfeeding woman (pregnancy urinary test before inclusion for women of childbearing age).

Trial population

Study participants are asymptomatic volunteers from the Constances cohort, whose risk factor profiles are representative of the population in the Île-de-France region (Paris area). Participants are divided into 6 decades from 20 to 80 years with equal distribution of men/women (200 men and 200 women per decade)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Imaging examinations

    Radiation

    * Cardiovascular and diaphragm MRI * Hepatic and kidney MRI * Hepatic ultrasound * Echocardiography

  • Paramedical examinations

    Other intervention

    * Urinary pregnancy test for women of childbearing age. * Blood sample for cardiometabolism profiling * Blood samples for biobanking (according to the information and consent form) * Impedancemetry * AGE reader: combined non-invasive measurement of aging and accumulation of glycated proteins in the subcutaneous tissue will be performed with a CE-marked device. * ECG

  • Medical examination

    Other intervention

    * Review of risk factors * Review of previous history * Recording of current medication (dci, dose, start date) * Recording of medication in the last 6 months and discontinued since (dci, dose, start date)

  • Echocardiography

    Other intervention

    Echocardiography including: 12-lead digital ECG

Treatment groups

2,400 Participants
are divided into 1 treatment group
Group A: Constances volunteers4 interventions

Trial outcomes

Primary outcomes

1

Establishement of reference nomograms accounting for age in heart

Ultrasound and MRI images analysis of qualitative and quantitative morphology, function, quantitative tissue characterization of the heart

Time frame
During 36 months of analysis (after 60 months of inclusion)
2

Establishement of reference nomograms accounting for sex in heart

Ultrasound and MRI images analysis of qualitative and quantitative morphology, function, quantitative tissue characterization of the heart

Time frame
During 36 months of analysis (after 60 months of inclusion)
3

Establishement of reference nomograms accounting for age in liver

Ultrasound and MRI images analysis of quantitative steatosis, fibrosis

Time frame
During 36 months of analysis (after 60 months of inclusion)
4

Establishement of reference nomograms accounting for sex in liver

Ultrasound and MRI images analysis of quantitative steatosis, fibrosis

Time frame
During 36 months of analysis (after 60 months of inclusion)

Secondary outcomes

1

Advanced Imaging profiling of Heart

Analysis of the cardiac cavities in 2D, 3D and in deformation by echocardiography analysis

Time frame
During 36 months of analysis (after 60 months of inclusion)
2

Advanced imaging profiling in Liver

Qualitative analysis of liver morphology and the nodularity of its boundaries, presence of ascites and portal derivation. Also presence of incidentaloma.

Time frame
During 36 months of analysis (after 60 months of inclusion)
3

Advanced biological phenotyping

Study of metabolic pathways and candidate biomarker suspected to be involved in aging

Time frame
During 36 months of analysis (after 60 months of inclusion)
4

identification of genetic risk markers for cardio-metabolic diseases

Defining the minimum set of markers useful for creating a risk score

Time frame
During 36 months of analysis (after 60 months of inclusion)

Other outcomes

Sponsors and contacts

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