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Multimodal kardiovaskulär och leverpopulationsavbildning (ICONIC)

15 september 2026 uppdaterad av: Institut National de la Santé Et de la Recherche Médicale, France

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

2400

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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)

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Strålning: Imaging examinations
  • Cardiovascular and diaphragm MRI
  • Hepatic and kidney MRI
  • Hepatic ultrasound
  • Echocardiography
Övrig: 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.
  • ECG
Övrig: 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)
Övrig: Echocardiography

Echocardiography including: 12-lead digital ECG

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Establishement of reference nomograms accounting for age in heart
Tidsram: 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
During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for sex in heart
Tidsram: 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
During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for age in liver
Tidsram: During 36 months of analysis (after 60 months of inclusion)

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

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

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

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 diaphragm
Tidsram: During 36 months of analysis (after 60 months of inclusion)

Ultrasound and MRI images analysis of diaphragm
During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for age in diaphragm
Tidsram: During 36 months of analysis (after 60 months of inclusion)

Ultrasound and MRI images analysis of diaphragm
During 36 months of analysis (after 60 months of inclusion)
Establishement of reference nomograms accounting for sex in kidney
Tidsram: During 36 months of analysis (after 60 months of inclusion)

Ultrasound and MRI images analysis of kidney
During 36 months of analysis (after 60 months of inclusion)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Advanced Imaging profiling of Heart
Tidsram: During 36 months of analysis (after 60 months of inclusion)

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
Tidsram: 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.
During 36 months of analysis (after 60 months of inclusion)
Advanced biological phenotyping
Tidsram: During 36 months of analysis (after 60 months of inclusion)

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

Defining the minimum set of markers useful for creating a risk score
During 36 months of analysis (after 60 months of inclusion)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 september 2025

Primärt slutförande (Beräknad)

14 mars 2030

Avslutad studie (Beräknad)

14 mars 2033

Studieregistreringsdatum

Först inskickad

10 december 2024

Först inskickad som uppfyllde QC-kriterierna

25 mars 2025

Första postat (Faktisk)

2 april 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 januari 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C24-17
  • 2024-A02188-39 (Annan identifierare: ANSM ID-RCB)

Plan för individuella deltagardata (IPD)

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