Prevalence of NAFLD in ACS Patients

Primary outcomes

1. FibroScan® liver stiffness measurements

   Time frame: 4 years

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

2. FibroScan® steatosis measurements

   Time frame: 4 years

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

3. Liver ultrasound

   Time frame: 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.

4. Liver biopsy results

   Time frame: 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.

5. Aspartate transaminase (AST)

   Time frame: 4 years

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

6. Alanine transaminase (ALT)

   Time frame: 4 years

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

7. Gamma glutamyltransferase (GGT)

   Time frame: 4 years

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

8. Lactate dehydrogenase (LDH)

   Time frame: 4 years

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

9. Exclusion of other liver diseases

   Time frame: 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.

10. Wellbeing - BAECKE

    Time frame: 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.

11. Wellbeing - GAD-7

    Time frame: 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.

12. Wellbeing - PHQ-9

    Time frame: 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.

13. Wellbeing - WPAI-SHP

    Time frame: 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.

14. Wellbeing-SF-36

    Time frame: 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.