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临床试验/NCT04774302
NCT04774302
已完成
不适用

Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease

Clinique Pasteur2 个研究点 分布在 1 个国家目标入组 292 人2021年3月18日
适应症NAFLD

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
NAFLD
发起方
Clinique Pasteur
入组人数
292
试验地点
2
主要终点
Coronary calcium score
状态
已完成
最后更新
上个月

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

注册库
clinicaltrials.gov
开始日期
2021年3月18日
结束日期
2025年4月30日
最后更新
上个月
研究类型
Observational
性别
All

研究者

责任方
Sponsor
主要研究者

Dr Maeva GUILLAUME

Principal investigator, MD

Clinique Pasteur

入排标准

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)

研究点 (2)

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