- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06906042
복합 심혈관 및 간 집단 영상 (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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Alban M Redheuil, PU-PH
- 전화번호: +33142165545
- 이메일: alban.redheuil@aphp.fr
연구 장소
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Paris, 프랑스
- 모병
- Hôpital Pitié-Salpêtrière
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연락하다:
- Louise M Meyfroit
- 전화번호: +33182847789
- 이메일: l.meyfroit@ihuican.org
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연락하다:
- Yasmin Mokhtari
- 이메일: yasmin.mokhtari@inserm.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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)
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Establishement of reference nomograms accounting for age in heart
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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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
기간: During 36 months of analysis (after 60 months of inclusion)
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Ultrasound and MRI images analysis of kidney |
During 36 months of analysis (after 60 months of inclusion)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Advanced Imaging profiling of Heart
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C24-17
- 2024-A02188-39 (기타 식별자: ANSM ID-RCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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