Multimodal Cardiovascular and Hepatic Population Imaging (ICONIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Imaging Evaluation
• Intervention / Treatment: Radiation: Imaging examinations; Other: Paramedical examinations; Other: Medical examination; Other: Echocardiography

• Study Type: Observational
• Enrollment (Estimated): 2400

Contacts and Locations

• Study Contact: Name: Alban M Redheuil, PU-PH; Phone Number: +33142165545; Email: alban.redheuil@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hôpital Pitié-Salpétrière
    • Contact: Louise M Meyfroit; Phone Number: +33182847789; Email: l.meyfroit@ihuican.org
    • Contact: Yasmin Mokhtari; Email: yasmin.mokhtari@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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)

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Constances volunteers; The 2400 volunteers will be stratifed according to age in decades from 20 to 80 years of age and matched 1:1 male:female.

Radiation: Imaging examinations; Cardiovascular MRI; Hepatic MRI; Hepatic ultrasound; Other: Paramedical examinations; 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.; Other: Medical examination; 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); Other: Echocardiography; Echocardiography including: 12-lead digital ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During 36 months of analysis (after 60 months of inclusion)
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	During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for age in liver	Ultrasound and MRI images analysis of quantitative steatosis, fibrosis	During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for sex in liver	Ultrasound and MRI images analysis of quantitative steatosis, fibrosis	During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for age in adipose tissue	Ultrasound and MRI images analysis of volumes of subcutaneous, visceral and epicardial adipose tissues	During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for sex in adipose tissue	Ultrasound and MRI images analysis of volumes of subcutaneous, visceral and epicardial adipose tissues	During 36 months of analysis (after 60 months of inclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced Imaging profiling of Heart	Analysis of the cardiac cavities in 2D, 3D and in deformation by echocardiography analysis	During 36 months of analysis (after 60 months of inclusion)
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.	During 36 months of analysis (after 60 months of inclusion)
Advanced biological phenotyping	Study of metabolic pathways and candidate biomarker suspected to be involved in aging	During 36 months of analysis (after 60 months of inclusion)
identification of genetic risk markers for cardio-metabolic diseases	Defining the minimum set of markers useful for creating a risk score	During 36 months of analysis (after 60 months of inclusion)

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): March 14, 2030
• Study Completion (Estimated): March 14, 2033

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Aging; reference values; liver; heart; multimodal imaging; population; Cardiac imaging; Constances cohort
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Quality of Health Care; Independent Medical Evaluation
• Other Study ID Numbers: C24-17; 2024-A02188-39 (Other Identifier: ANSM ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No