NCT02779946

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 216 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Disease
• Non-alcoholic Fatty Liver Disease
• Elasticity Imaging Techniques

Interventions

Type	Name	Description
DEVICE	Fibro Scan
GENETIC	PNPLA3

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2016-05-23
• Last updated: 2017-06-16

Locations

1 site across 1 country: Germany