Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Coronary calcium score
研究概览
简要总结
This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.
详细描述
Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
- •Patient without known heart disease
- •Patient agreeing to participate and who has given his non opposition
排除标准
- •Association with another cause of liver disease
- •Already known coronary artery disease
- •Pregnancy or breastfeeding in progress
结局指标
主要结局
Coronary calcium score
时间窗: At inclusion
Score in Agatston IU of coronary atherosclerosis risk;ranging from 0 to 100 : low risk; 100 to 400 : intermediate risk and \> 400 : high risk of coronary atherosclerosis.
Shear wave liver elastography
时间窗: At inclusion
Hepatic elasticity assessed in kPa : \<5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; \> 8 kPa : advanced fibrosis; \>15 kPa : cirrhosis
次要结局
- ARFI Hepatic elasticity(At inclusion)
- Cardiovascular risk(At inclusion)
- Coronary heart disease(3 month)
研究者
Dr Maeva GUILLAUME
Principal investigator, MD
Clinique Pasteur