Multimodal Cardiovascular and Hepatic Population Imaging

NCT06906042 | Recruiting

• 2 other identifiers: C24-172024-A02188-39
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers; Imaging Evaluation

Keywords

multimodal imaging; heart; liver; Constances cohort; population; Cardiac imaging; MRI; Aging; reference values

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Advanced Imaging profiling of Heart

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

• Advanced imaging profiling in Liver

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

• Advanced biological phenotyping

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

• identification of genetic risk markers for cardio-metabolic diseases

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

Study Arms (1)

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; Other: Paramedical examinations; Other: Medical examination; Other: Echocardiography

Interventions

Imaging examinations RADIATION

* Cardiovascular MRI * Hepatic MRI * Hepatic ultrasound

Constances volunteers

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.

Constances volunteers

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)

Constances volunteers

Echocardiography OTHER

Echocardiography including: 12-lead digital ECG

Constances volunteers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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…)

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 36125376 RESULT

• 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.

  PMID: 30244673 RESULT

• 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.

  PMID: 35263580 RESULT

• 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.

  PMID: 31203728 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Biobank blood samples (16 ml) will be collected and stored as follows:. * Dry blood tubes (8ml) for the constitution of a serum collection, stored in aliquots. * EDTA blood tubes (8 ml) for the constitution of a plasma collection, stored in aliquots. * For subjects who consent to genetic analysis (no additional intake) and according to the informed consent, the EDTA tube will be kepted at the CRB ICAN for future DNA extraction for ICONIC or further research.

MeSH Terms

Interventions

Independent Medical Evaluation

Intervention Hierarchy (Ancestors)

Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Alban M Redheuil, PU-PH

CONTACT

+33142165545; alban.redheuil@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: April 2, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): March 14, 2030
• Study Completion (Estimated): March 14, 2033
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (1)