Multimodal Cardiovascular and Hepatic Population Imaging

Обзор

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.

Вмешательства

• Лучевая терапия Imaging examinations
  * Cardiovascular MRI * Hepatic MRI * Hepatic ultrasound
• Другое 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.
• Другое 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)
• Другое Echocardiography
  Echocardiography including: 12-lead digital ECG

Первичные конечные точки

• Establishement of reference nomograms accounting for age in heart [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Establishement of reference nomograms accounting for sex in heart [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Establishement of reference nomograms accounting for age in liver [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Establishement of reference nomograms accounting for sex in liver [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Establishement of reference nomograms accounting for age in adipose tissue [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Establishement of reference nomograms accounting for sex in adipose tissue [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]

Вторичные конечные точки (4)

• Advanced Imaging profiling of Heart [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Advanced imaging profiling in Liver [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• Advanced biological phenotyping [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]
• identification of genetic risk markers for cardio-metabolic diseases [Срок оценки: During 36 months of analysis (after 60 months of inclusion)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hôpital Pitié-Salpêtrière — Paris

Публикации

• 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. PMID 36125376
• 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. PMID 30244673
• 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. PMID 35263580
• 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. PMID 31203728

Идентификаторы

NCT: NCT06906042 · C24-17 · 2024-A02188-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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