Prevalence of NAFLD in ACS Patients

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
NAFLD, ACS - Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Non-invasive diagnostic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years having acute cardiovascular syndrome able to understand Dutch able to understand the informed consent Exclusion Criteria: excessive alcohol abuse other liver disease secondary causes of steatosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ACS risk gropu<br>Group of patients with an acute-cardiovascular syndrome. | Diagnostic Test: Non-invasive diagnostic testing<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 4 years | 
| Aspartate transaminase (AST) | Out of the EPF the blood parameter AST (U/L) will be collected. | 4 years | 
| Alanine transaminase (ALT) | Out of the EPF the blood parameter ALT (U/L) will be collected. | 4 years | 
| Gamma glutamyltransferase (GGT) | Out of the EPF the blood parameter GGT (U/L) will be collected. | 4 years | 
| Lactate dehydrogenase (LDH) | Out of the EPF the blood parameter LDH (U/L) will be collected. | 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. | 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. | 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. | 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. | 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. | 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. | 4 years |