Clinical trial NCT06906042: Multimodal Cardiovascular and Hepatic Population Imaging
Official title: Multimodal Cardiovascular and Hepatic Population Imaging
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy Volunteers
Imaging Evaluation
Keywords: multimodal imaging
heart
liver
Constances cohort
population
Cardiac imaging
MRI
Aging
reference values
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2025-04-02
Enrollment: 2400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Establishement of reference nomograms accounting for age in heart
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Establishement of reference nomograms accounting for sex in heart
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Establishement of reference nomograms accounting for age in liver
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Establishement of reference nomograms accounting for sex in liver
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Establishement of reference nomograms accounting for age in adipose tissue
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Establishement of reference nomograms accounting for sex in adipose tissue
timeFrame: During 36 months of analysis (after 60 months of inclusion)
Secondary outcomes:
measure: Advanced Imaging profiling of Heart
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Advanced imaging profiling in Liver
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: Advanced biological phenotyping
timeFrame: During 36 months of analysis (after 60 months of inclusion)
measure: identification of genetic risk markers for cardio-metabolic diseases
timeFrame: During 36 months of analysis (after 60 months of inclusion)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.