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NCT Number: NCT06906042

Multimodal Cardiovascular and Hepatic Population Imaging

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.

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation to the Constances cohort
  • Age ≥ 20 years
  • No overt cardiovascular or hepatic disease or related symptoms
  • No known family or personal genetic disease
  • Affiliation with a social security scheme or beneficiary of such a scheme.
  • Agreement to sign the consent

Exclusion criteria

  • 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).

Treatment and study plan

Imaging examinations

Radiation
  • Cardiovascular MRI
  • Hepatic MRI
  • Hepatic ultrasound

Paramedical examinations

Other
  • 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.

Medical examination

Other
  • 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

Echocardiography including: 12-lead digital ECG

Primary outcomes

  1. Establishement of reference nomograms accounting for age in heart

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

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

  2. Establishement of reference nomograms accounting for sex in heart

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

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

  3. Establishement of reference nomograms accounting for age in liver

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

    Ultrasound and MRI images analysis of quantitative steatosis, fibrosis

  4. Establishement of reference nomograms accounting for sex in liver

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

    Ultrasound and MRI images analysis of quantitative steatosis, fibrosis

  5. Establishement of reference nomograms accounting for age in adipose tissue

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

    Ultrasound and MRI images analysis of volumes of subcutaneous, visceral and epicardial adipose tissues

  6. Establishement of reference nomograms accounting for sex in adipose tissue

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

    Ultrasound and MRI images analysis of volumes of subcutaneous, visceral and epicardial adipose tissues

Secondary outcomes

  1. Advanced Imaging profiling of Heart

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

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

  2. Advanced imaging profiling in Liver

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

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

  3. Advanced biological phenotyping

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

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

  4. identification of genetic risk markers for cardio-metabolic diseases

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alban M Redheuil, PU-PH

CONTACT

[email protected]

+33142165545

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Acronym: ICONIC

Important dates

Study start
2025
Primary completion
2030
Study completion
2033
First posted
Apr 2, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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