Prevalence of NAFLD in ACS Patients (PADAC)
Primary Purpose
NAFLD, ACS - Acute Coronary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Non-invasive diagnostic testing
Sponsored by
About this trial
This is an interventional screening trial for NAFLD
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
Sites / Locations
- Ziekenhuis Oost-LimburgRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ACS risk gropu
Arm Description
Group of patients with an acute-cardiovascular syndrome.
Outcomes
Primary Outcome Measures
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.
FibroScan® steatosis measurements
The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.
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.
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.
Aspartate transaminase (AST)
Out of the EPF the blood parameter AST (U/L) will be collected.
Alanine transaminase (ALT)
Out of the EPF the blood parameter ALT (U/L) will be collected.
Gamma glutamyltransferase (GGT)
Out of the EPF the blood parameter GGT (U/L) will be collected.
Lactate dehydrogenase (LDH)
Out of the EPF the blood parameter LDH (U/L) will be collected.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05378321
Brief Title
Prevalence of NAFLD in ACS Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, ACS - Acute Coronary Syndrome
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACS risk gropu
Arm Type
Other
Arm Description
Group of patients with an acute-cardiovascular syndrome.
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-invasive diagnostic testing
Intervention Description
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
Primary Outcome Measure Information:
Title
FibroScan® liver stiffness measurements
Description
The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.
Time Frame
4 years
Title
FibroScan® steatosis measurements
Description
The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.
Time Frame
4 years
Title
Liver ultrasound
Description
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.
Time Frame
4 years
Title
Liver biopsy results
Description
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.
Time Frame
4 years
Title
Aspartate transaminase (AST)
Description
Out of the EPF the blood parameter AST (U/L) will be collected.
Time Frame
4 years
Title
Alanine transaminase (ALT)
Description
Out of the EPF the blood parameter ALT (U/L) will be collected.
Time Frame
4 years
Title
Gamma glutamyltransferase (GGT)
Description
Out of the EPF the blood parameter GGT (U/L) will be collected.
Time Frame
4 years
Title
Lactate dehydrogenase (LDH)
Description
Out of the EPF the blood parameter LDH (U/L) will be collected.
Time Frame
4 years
Title
Exclusion of other liver diseases
Description
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.
Time Frame
4 years
Title
Wellbeing - BAECKE
Description
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.
Time Frame
4 years
Title
Wellbeing - GAD-7
Description
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.
Time Frame
4 years
Title
Wellbeing - PHQ-9
Description
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.
Time Frame
4 years
Title
Wellbeing - WPAI-SHP
Description
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.
Time Frame
4 years
Title
Wellbeing-SF-36
Description
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.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Robaeys, Phd. MD.
Phone
089 32 65 05
Ext
32
Email
geert.robaeys@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Leen Heyens, drs
Phone
089 21 20 55
Ext
32
Email
leen.heyens@uhasselt.be
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, PhD. MD.
Phone
089 32 6505
Ext
32
Email
geert.robaeys@zol.be
First Name & Middle Initial & Last Name & Degree
Leen Heyens, drs
Phone
089 21 2055
Ext
32
Email
leen.heyens@uhasselt.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prevalence of NAFLD in ACS Patients
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