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Healthy VolunteersICONICNCT06906042

Multimodal Cardiovascular and Hepatic Population Imaging

An observational study of Healthy Volunteers and Imaging Evaluation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Imaging Evaluation
What is being tested?
Imaging examinations, Paramedical examinations and Medical examination
How many people
2,400 participants
Where
1 siteFrance
Study dates
15 Sep 2025to 14 Mar 2033
How long will I take part?
1 Day
Phase
Observational
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study 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)

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alban M Redheuil, PU-PH contact

+33142165545

alban.redheuil@aphp.fr

France1 site, 1 recruiting

  • Hôpital Pitié-Salpêtrière

    Paris

    Louise M Meyfroit, +33182847789, l.meyfroit@ihuican.org

    Yasmin Mokhtari, yasmin.mokhtari@inserm.fr

    Recruiting

Other trials in France

About this study

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.

Being tested
Imaging examinations, Paramedical examinations, Medical examination, Echocardiography
Keywords
multimodal imaging, heart, liver, Constances cohort, population, Cardiac imaging, MRI, Aging, reference values, diaphragm, kidney

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imaging examinationsRadiation

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

  • Paramedical examinationsOther

    • 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 examinationOther

    • 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)

  • EchocardiographyOther

    Echocardiography including: 12-lead digital ECG

Study groups in NCT06906042
Study groupRoleWhat they receive
Constances volunteersThe 2400 volunteers will be stratifed according to age in decades from 20 to 80 years of age and matched 1:1 male:female.
Receives: Radiation: Imaging examinations; Other: Paramedical examinations; Other: Medical examination; Other: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: During 36 months of analysis (after 60 months of inclusion)

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

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

    Measured: During 36 months of analysis (after 60 months of inclusion)

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

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

    Measured: During 36 months of analysis (after 60 months of inclusion)

  7. Establishement of reference nomograms accounting for sex in diaphragm

    Ultrasound and MRI images analysis of diaphragm

    Measured: During 36 months of analysis (after 60 months of inclusion)

  8. Establishement of reference nomograms accounting for age in diaphragm

    Ultrasound and MRI images analysis of diaphragm

    Measured: During 36 months of analysis (after 60 months of inclusion)

  9. Establishement of reference nomograms accounting for sex in kidney

    Ultrasound and MRI images analysis of kidney

    Measured: During 36 months of analysis (after 60 months of inclusion)

Secondary outcomes (4)

  1. Advanced Imaging profiling of Heart

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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: During 36 months of analysis (after 60 months of inclusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start15 Sep 2025
  3. Primary completion14 Mar 2030 (estimated)
  4. Study completion14 Mar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,400 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906042
Sponsor's protocol ID
C24-17
Other IDs
2024-A02188-39
Acronym
ICONIC
Status last verified
Jan 2026
First submitted
10 Dec 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mauger CA, Gilbert K, Suinesiaputra A, Bluemke DA, Wu CO, Lima JAC, Young AA, Ambale-Venkatesh B. Multi-Ethnic Study of Atherosclerosis: Relationship between Left Ventricular Shape at Cardiac MRI and 10-year Outcomes. Radiology. 2023 Feb;306(2):e220122. doi: 10.1148/radiol.220122. Epub 2022 Sep 20.

    PubMed 36125376

  • Bohnen S, Avanesov M, Jagodzinski A, Schnabel RB, Zeller T, Karakas M, Schneider J, Tahir E, Cavus E, Spink C, Radunski UK, Ojeda F, Adam G, Blankenberg S, Lund GK, Muellerleile K. Cardiovascular magnetic resonance imaging in the prospective, population-based, Hamburg City Health cohort study: objectives and design. J Cardiovasc Magn Reson. 2018 Sep 24;20(1):68. doi: 10.1186/s12968-018-0490-7.

    PubMed 30244673

  • Nie C, Li Y, Li R, Yan Y, Zhang D, Li T, Li Z, Sun Y, Zhen H, Ding J, Wan Z, Gong J, Shi Y, Huang Z, Wu Y, Cai K, Zong Y, Wang Z, Wang R, Jian M, Jin X, Wang J, Yang H, Han JJ, Zhang X, Franceschi C, Kennedy BK, Xu X. Distinct biological ages of organs and systems identified from a multi-omics study. Cell Rep. 2022 Mar 8;38(10):110459. doi: 10.1016/j.celrep.2022.110459.

    PubMed 35263580

  • Laurent S, Boutouyrie P, Cunha PG, Lacolley P, Nilsson PM. Concept of Extremes in Vascular Aging. Hypertension. 2019 Aug;74(2):218-228. doi: 10.1161/HYPERTENSIONAHA.119.12655. Epub 2019 Jun 17. No abstract available.

    PubMed 31203728

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers and Imaging Evaluation, run by Institut National de la Santé Et de la Recherche Médicale, 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 6 inclusion and 4 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 18 Sep 2026. 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?

Contact Alban M Redheuil, PU-PH (+33142165545, alban.redheuil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establishement of reference nomograms accounting for age in heart (time frame: During 36 months of analysis (after 60 months of inclusion)). 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?

On the ClinicalTrials.gov record for NCT06906042, which also lists 4 linked publications.

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 18 Sep 2026.

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ICONIC Clinical Trial NCT06906042 | AzTrials