Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease

Study Overview
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Brief Summary
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Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.

Official Title
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Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease

Conditions
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Coronary Disease, Non-alcoholic Fatty Liver Disease, Elasticity Imaging Techniques

Intervention / Treatment
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* Device: Fibro Scan
* Genetic: PNPLA3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent age ≥ 18 years patients with indication for routine coronary angiography Exclusion Criteria: transplanted liver resection of right liver lobe transaminases of > 5-fold upper limit pregnancy or lactation choleastasis on ultrasound imaging active malignant or consuming disease 12 month before inclusion congestive heart failure (EF<30%, NYHA III or IV, diastolic dysfunction °III or IV pulmonary hypertension (WHO °III or IV) Exclusion criteria for MR diagnostics pacemaker or ICD non removable magnetizable metal implants claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHD-positive<br>positive tested for coronary artery disease | Device: Fibro Scan<br> <br> Genetic: PNPLA3<br> <br> |
| CHD-negative<br>negative tested for coronary artery disease | Device: Fibro Scan<br> <br> Genetic: PNPLA3<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of presence CHD and NAFLD | Routine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of severity of CHD and NAFLD | Correlation of severity of CHD defined by angiography (Multi or Single vessel disease) will be correlated by quantification of liver fibrosis and steatosis on Fibroscan. | 1 year | 
| Fibrocan vs MR-based methods | MRS will be evaluated and correlated to the results of Fibroscan in a subset of patients. | 1 year | 
| Correlation of NAFLD and intima media thickness | intima media thickness of the common carotid artery is correlated to the Fibroscan results | 1 year | 
| Correlation of NAFLD and other signs of atherosclerosis | Plaque burden of abdominal aorta and carotid artery will be correlated to the results of Fibroscan. | 1 year |