Prevalence of NAFLD in ACS Patients

NAFLD Clinical Trial

— PADAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378321
• Other study ID #: PADAC-01
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2024
• Source: Ziekenhuis Oost-Limburg
• Contact: Geert Robaeys, Phd. MD.
• Phone: 089 32 65 05
• Email: geert.robaeys[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACS - Acute Coronary Syndrome
• Acute Coronary Syndrome
• NAFLD

Intervention

Diagnostic Test:
• Non-invasive diagnostic testing
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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Aspartate transaminase (AST)	Out of the EPF the blood parameter AST (U/L) will be collected.	4 years
Primary	Alanine transaminase (ALT)	Out of the EPF the blood parameter ALT (U/L) will be collected.	4 years
Primary	Gamma glutamyltransferase (GGT)	Out of the EPF the blood parameter GGT (U/L) will be collected.	4 years
Primary	Lactate dehydrogenase (LDH)	Out of the EPF the blood parameter LDH (U/L) will be collected.	4 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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