Risk Factors for Advanced Fibrosis Among Fatty Liver Disease Patients Identified Through Pharese-screening of Miaging Reports
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- remission of fatty liver disease
研究概览
简要总结
The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.
To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. Within the data lake of Helsinki University Hospital, they identified a large number of individuals with or without FLD. The investigators will now randomly invite 1000-1500 individuals with FLD to a follow-up study including investigation of metabolism and progression of liver disease (elastography, blood tests) as well as gathering life-style information. Register data on previous diagnoses and medication will be used to evaluate cardiovascular disease.
详细描述
The investigators investigate the heterogeneity fatty liver disease (FLD) as well as risk factors associated with progression of the liver diseases or development of cardiovascular complication. The overarching aim is to develop a AI-based prediction model that could be integrated into the electronic medical record system.
To identify large numbers of unselected individuals with FLD, the investigators developed a phrase recognition algorithm, which identifies FLD using radiology reports. This allows them to study also individuals who have had abdominal imaging for any reason (usually not for suspected liver disease). Within the data lake of Helsinki University Hospital, the investigators identified 61,271 individuals with FLD and 155,521 without. The investigators have obtained national register data on their diagnosed diseases and medication.
The investigators will now invite a random sample of 1000-1500 individuals with FLD (aged 20-60 years at the time of the previous imaging) to a follow-up study. Progression of liver disease will be studied by elastography, measurement of fat content and a blood sample for fibrosis markes (ELF score). The participants' metabolism will be evaluated with several laboraroty tests and an i.v. glucagon tolerance test and amino acid response. Questionnaires will be used to obtain life-style information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver imaging results in the Helsinki University Hospital datalake 2010-2018 and a finding of fatty liver disease (without liver cirrhosis)
- •Age 25-70 years(20-60 yrs at the time of the index imaging (2010-2018)
- •Biobank consent with the Helsinki Biobank to be contacted for possible studies
排除标准
- •Liver cirrhosis at index imaging date; pregnancy; active treatment for cancer
结局指标
主要结局
remission of fatty liver disease
时间窗: 5-15 years
Proportion of participants with remission of fatty liver (= no detectable liver fat) since the index date (in 2010-2018)
Progression of liver disease
时间窗: 5-15 years
Proportion of participants who have developed liver fibrosis or steatosis since the index date (in 2010-2018)
次要结局
未报告次要终点
研究者
Tiinamaija Tuomi
Chief Physician
Helsinki University Central Hospital