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临床试验/NCT05378321
NCT05378321已完成不适用

The Prevalence of Non-Alcoholic Fatty Liver Disease in Patients With an Acute Cardiac Event Followed at Ziekenhuis Oost-Limburg, Genk, Belgium

Ziekenhuis Oost-Limburg2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
225
试验地点
2
主要终点
Aspartate transaminase (AST)

研究概览

简要总结

Addressing CVD risk in patients with NAFLD is the aspect of the disease most amenable to medical management and so improving long-term clinical outcomes. Almost no studies have been done concerning the prevalence of NAFLD in CVD patients, most of the conducted studies have been done in already diagnosed NAFLD patients to estimate the risk of CVD development. Currently, there are no data available about the prevalence of NAFLD in CVD, more specifically patients with an acute cardiovascular event (ACE) in Belgium.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years
  • having acute cardiovascular syndrome
  • able to understand Dutch
  • able to understand the informed consent

排除标准

  • excessive alcohol abuse
  • other liver disease
  • secondary causes of steatosis

研究组 & 干预措施

ACS risk gropu

Other

Group of patients with an acute-cardiovascular syndrome.

干预措施: Non-invasive diagnostic testing (Diagnostic Test)

结局指标

主要结局

Aspartate transaminase (AST)

时间窗: 4 years

Out of the EPF the blood parameter AST (U/L) will be collected.

Lactate dehydrogenase (LDH)

时间窗: 4 years

Out of the EPF the blood parameter LDH (U/L) will be collected.

Wellbeing - WPAI-SHP

时间窗: 4 years

Workers Productivity and Activity Impairment (WPAI-SHP) questionnaire. By means of 6 questions about work productivity and activity it can be determined if there is absence, productivity loss or a decrease in activities at work. The score is expressed in percentages (0-100). A higher percentage indicates a higher absence from work and a lower productivity.

FibroScan® liver stiffness measurements

时间窗: 4 years

The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.

FibroScan® steatosis measurements

时间窗: 4 years

The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.

Liver ultrasound

时间窗: 4 years

Out of the EPF the results of a possible earlier ultrasound are noted in the CRF. The results are noted as 'liver steatosis found' with yes/no answer and the year in which this ultrasound was performed.

Alanine transaminase (ALT)

时间窗: 4 years

Out of the EPF the blood parameter ALT (U/L) will be collected.

Liver biopsy results

时间窗: 4 years

Out of the EPF the results of a possible earlier ultrasound or liver biopsy are noted in the CRF. The NAS CRN (histological) score is noted. The score ranges from 0-8 and is composed of the unweighted sum of steatosis, ballooning, and lobular inflammation. A score between 0-2 corresponds to no NASH, 3-4 is borderline NASH, and definite NASH has a score between 5 and 8.

Exclusion of other liver diseases

时间窗: 4 years

hepatitis B, hepatitis C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson disease and alpha 1 antitrypsin deficiency. NAFLD is a disease of exclusion and therefore the abovementioned parameters are determined out of the EPF.

Gamma glutamyltransferase (GGT)

时间窗: 4 years

Out of the EPF the blood parameter GGT (U/L) will be collected.

Wellbeing - BAECKE

时间窗: 4 years

This questionnaire will be used to estimate the level of physical activity. It exists out of 16 questions about work, sports and leisure time. A higher score means that the person is more active at work, does more sport and has a more active leisure time. Minimum value is 3 and maximum value is 15.

Wellbeing - GAD-7

时间窗: 4 years

General Anxiety Disorder (GAD-7) questionnaire will be used to determine the presence of possible clinically significant anxiety disorder. A higher scores indicates having anxiety. Minimum score is 0 and maximum score is 21.

Wellbeing - PHQ-9

时间窗: 4 years

Patient Health Questionnaire-9 (PHQ-9) will be used to quantify depression symptoms and monitor severity. Minimum score is 0 and maximum score is 27. A higher score indicates having a depression.

Wellbeing-SF-36

时间窗: 4 years

Short Form Health Survey-36 will be used to determine the health related quality of life based on 6 different topics: physical functioning, social functioning, role restrictions, mental wellbeing, energy and pain. The score is expressed in percentages (0-100). A higher percentage indicates a better general wellbeing.

次要结局

未报告次要终点

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathieu Struyve

Principal Investigator

Ziekenhuis Oost-Limburg

研究点 (2)

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