- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06906042
Imagem da população cardiovascular e hepática multimodal (ICONIC)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Alban M Redheuil, PU-PH
- Número de telefone: +33142165545
- E-mail: alban.redheuil@aphp.fr
Locais de estudo
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Paris, França
- Recrutamento
- Hôpital Pitié-Salpêtrière
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Contato:
- Louise M Meyfroit
- Número de telefone: +33182847789
- E-mail: l.meyfroit@ihuican.org
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Contato:
- Yasmin Mokhtari
- E-mail: yasmin.mokhtari@inserm.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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)
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
Echocardiography including: 12-lead digital ECG |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Establishement of reference nomograms accounting for age in heart
Prazo: 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)
|
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Establishement of reference nomograms accounting for sex in heart
Prazo: 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)
|
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Establishement of reference nomograms accounting for age in liver
Prazo: 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)
|
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Establishement of reference nomograms accounting for sex in liver
Prazo: 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)
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Establishement of reference nomograms accounting for age in adipose tissue
Prazo: 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)
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Establishement of reference nomograms accounting for sex in adipose tissue
Prazo: 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)
|
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Establishement of reference nomograms accounting for sex in diaphragm
Prazo: 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)
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Establishement of reference nomograms accounting for age in diaphragm
Prazo: 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)
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Establishement of reference nomograms accounting for sex in kidney
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Advanced Imaging profiling of Heart
Prazo: During 36 months of analysis (after 60 months of inclusion)
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Analysis of the cardiac cavities in 2D, 3D and in deformation by echocardiography analysis |
During 36 months of analysis (after 60 months of inclusion)
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Advanced imaging profiling in Liver
Prazo: During 36 months of analysis (after 60 months of inclusion)
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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)
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Advanced biological phenotyping
Prazo: During 36 months of analysis (after 60 months of inclusion)
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Study of metabolic pathways and candidate biomarker suspected to be involved in aging |
During 36 months of analysis (after 60 months of inclusion)
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identification of genetic risk markers for cardio-metabolic diseases
Prazo: During 36 months of analysis (after 60 months of inclusion)
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Defining the minimum set of markers useful for creating a risk score |
During 36 months of analysis (after 60 months of inclusion)
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Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C24-17
- 2024-A02188-39 (Outro identificador: ANSM ID-RCB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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