Multimodal Cardiovascular and Hepatic Population Imaging

Not yet recruiting

• Conditions: Healthy Volunteers; Imaging Evaluation

• Registration Number: NCT06906042
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-05-15
• Primary Completion: 2030-03-14
• Study Completion: 2033-03-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France