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Multimodal kardiovaskulær og leverpopulasjonsavbildning (ICONIC)

15. september 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

2400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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
Annen: 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
Annen: 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)
Annen: Echocardiography

Echocardiography including: 12-lead digital ECG

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. september 2025

Primær fullføring (Antatt)

14. mars 2030

Studiet fullført (Antatt)

14. mars 2033

Datoer for studieregistrering

Først innsendt

10. desember 2024

Først innsendt som oppfylte QC-kriteriene

25. mars 2025

Først lagt ut (Faktiske)

2. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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