Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Correlation of presence CHD and NAFLD
研究概览
简要总结
Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.
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
- •informed consent
- •age ≥ 18 years
- •patients with indication for routine coronary angiography
排除标准
- •transplanted liver
- •resection of right liver lobe
- •transaminases of > 5-fold upper limit
- •pregnancy or lactation
- •choleastasis on ultrasound imaging
- •active malignant or consuming disease 12 month before inclusion
- •congestive heart failure (EF<30%, NYHA III or IV, diastolic dysfunction °III or IV
- •pulmonary hypertension (WHO °III or IV) Exclusion criteria for MR diagnostics
- •pacemaker or ICD
- •non removable magnetizable metal implants
- •claustrophobia
结局指标
主要结局
Correlation of presence CHD and NAFLD
时间窗: 1 year
Routine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present.
次要结局
- Correlation of severity of CHD and NAFLD(1 year)
- Fibrocan vs MR-based methods(1 year)
- Correlation of NAFLD and intima media thickness(1 year)
- Correlation of NAFLD and other signs of atherosclerosis(1 year)
研究者
Sebastian Beer
Specialist in Internal Medicine, Principle Investigator
University of Leipzig