NAFLDPADACNCT05378321
Prevalence of NAFLD in ACS Patients
A study testing Non-invasive diagnostic testing in people with NAFLD and ACS - Acute Coronary Syndrome, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, ACS - Acute Coronary Syndrome
- What is being tested?
- Non-invasive diagnostic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- having acute cardiovascular syndrome
- able to understand Dutch
- able to understand the informed consent
Who cannot join
- excessive alcohol abuse
- other liver disease
- secondary causes of steatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- NAFLD, ACS - Acute Coronary Syndrome
- Being tested
- Non-invasive diagnostic testing
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive diagnostic testingDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| ACS risk gropu | Other | Group of patients with an acute-cardiovascular syndrome. Receives: Diagnostic Test: Non-invasive diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years
Aspartate transaminase (AST)
Out of the EPF the blood parameter AST (U/L) will be collected.
Measured: 4 years
Alanine transaminase (ALT)
Out of the EPF the blood parameter ALT (U/L) will be collected.
Measured: 4 years
Gamma glutamyltransferase (GGT)
Out of the EPF the blood parameter GGT (U/L) will be collected.
Measured: 4 years
Lactate dehydrogenase (LDH)
Out of the EPF the blood parameter LDH (U/L) will be collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Feb 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu Struyve, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378321
- Sponsor's protocol ID
- PADAC-01
- Acronym
- PADAC
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Non-Alcoholic Fatty Liver Disease in Patients With an Acute Cardiac Event Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
- ClinicalTrials.gov ID
- NCT05378321
- Acronym / sponsor ID
- PADAC / PADAC-01
- Conditions
- NAFLD, ACS - Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS risk gropu | Other | Diagnostic Test: Non-invasive diagnostic testingGroup of patients with an acute-cardiovascular syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years
- having acute cardiovascular syndrome
- able to understand Dutch
- able to understand the informed consent
Key exclusion criteria (3 listed)
- excessive alcohol abuse
- other liver disease
- secondary causes of steatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive diagnostic testingNon-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 | Diagnostic test | ACS risk gropu |
Primary outcome
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.
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.
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.
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.
Aspartate transaminase (AST)
Time frame: 4 years
Out of the EPF the blood parameter AST (U/L) will be collected.
Alanine transaminase (ALT)
Time frame: 4 years
Out of the EPF the blood parameter ALT (U/L) will be collected.
Gamma glutamyltransferase (GGT)
Time frame: 4 years
Out of the EPF the blood parameter GGT (U/L) will be collected.
Lactate dehydrogenase (LDH)
Time frame: 4 years
Out of the EPF the blood parameter LDH (U/L) will be collected.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive diagnostic testing in people with NAFLD and ACS - Acute Coronary Syndrome, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FibroScan® liver stiffness measurements (time frame: 4 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.