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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
225
Non-invasive diagnostic testing consists of the use of the FibroScan device and the calculation of non-invasive blood-based scores for the diagnosis of NAFLD
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
FibroScan® liver stiffness measurements
The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.
Time frame: 4 years
FibroScan® steatosis measurements
The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.
Time frame: 4 years
Liver ultrasound
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.
Time frame: 4 years
Liver biopsy results
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.
Time frame: 4 years
Aspartate transaminase (AST)
Out of the EPF the blood parameter AST (U/L) will be collected.
Time frame: 4 years
Alanine transaminase (ALT)
Out of the EPF the blood parameter ALT (U/L) will be collected.
Time frame: 4 years
Gamma glutamyltransferase (GGT)
Out of the EPF the blood parameter GGT (U/L) will be collected.
Time frame: 4 years
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Lactate dehydrogenase (LDH)
Out of the EPF the blood parameter LDH (U/L) will be collected.
Time frame: 4 years
Exclusion of other liver diseases
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.
Time frame: 4 years
Wellbeing - BAECKE
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.
Time frame: 4 years
Wellbeing - GAD-7
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.
Time frame: 4 years
Wellbeing - PHQ-9
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.
Time frame: 4 years
Wellbeing - WPAI-SHP
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.
Time frame: 4 years
Wellbeing-SF-36
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.
Time frame: 4 years