Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Multimodal kardiovaskulær og leverpopulationsafbildning (ICONIC)

15. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
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.
Stråling: Imaging examinations
  • Cardiovascular and diaphragm MRI
  • Hepatic and kidney MRI
  • Hepatic ultrasound
  • Echocardiography
Andet: 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
Andet: 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)
Andet: Echocardiography

Echocardiography including: 12-lead digital ECG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Establishement of reference nomograms accounting for age in heart
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Advanced Imaging profiling of Heart
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. september 2025

Primær færdiggørelse (Anslået)

14. marts 2030

Studieafslutning (Anslået)

14. marts 2033

Datoer for studieregistrering

Først indsendt

10. december 2024

Først indsendt, der opfyldte QC-kriterier

25. marts 2025

Først opslået (Faktiske)

2. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C24-17
  • 2024-A02188-39 (Anden identifikator: ANSM ID-RCB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner