Prevalence of NAFLD in ACS Patients (PADAC)

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

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 Overview

• Status: Recruiting
• Conditions: NAFLD; ACS - Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Non-invasive diagnostic testing

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geert Robaeys, Phd. MD.; Phone Number: 32 089 32 65 05; Email: geert.robaeys@zol.be
• Study Contact Backup: Name: Leen Heyens, drs; Phone Number: 32 089 21 20 55; Email: leen.heyens@uhasselt.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Geert Robaeys, PhD. MD.; Phone Number: 32 089 32 6505; Email: geert.robaeys@zol.be
      • Contact: Leen Heyens, drs; Phone Number: 32 089 21 2055; Email: leen.heyens@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ACS risk gropu; Group of patients with an acute-cardiovascular syndrome.	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

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

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: PADAC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No