多模式心血管和肝种群成像 (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.
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Alban M Redheuil, PU-PH
- 电话号码：+33142165545
- 邮箱：alban.redheuil@aphp.fr
学习地点
-
-
-
Paris、法国
- 招聘中
- Hôpital Pitié-Salpêtrière
-
接触：
- Louise M Meyfroit
- 电话号码：+33182847789
- 邮箱：l.meyfroit@ihuican.org
-
接触：
- Yasmin Mokhtari
- 邮箱：yasmin.mokhtari@inserm.fr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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)
描述
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).
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Establishement of reference nomograms accounting for age in heart
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Advanced Imaging profiling of Heart
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.