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Clinical Trials/NCT06906042
NCT06906042RecruitingNot Applicable

Multimodal Cardiovascular and Hepatic Population Imaging

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country2,400 target enrollmentStarted: September 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,400
Locations
1
Primary Endpoint
Establishement of reference nomograms accounting for sex in diaphragm

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

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.

Intervention: Imaging examinations (Radiation)

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.

Intervention: Paramedical examinations (Other)

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.

Intervention: Medical examination (Other)

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.

Intervention: Echocardiography (Other)

Outcomes

Primary Outcomes

Establishement of reference nomograms accounting for sex in diaphragm

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

Ultrasound and MRI images analysis of diaphragm

Establishement of reference nomograms accounting for age in diaphragm

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

Ultrasound and MRI images analysis of diaphragm

Establishement of reference nomograms accounting for sex in kidney

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

Ultrasound and MRI images analysis of kidney

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

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

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

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

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

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

  • 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))

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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