Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease (NILS-R-CHD)

University of Leipzig

Status: Completed

Conditions: Elasticity Imaging Techniques; Non-alcoholic Fatty Liver Disease; Coronary Disease

Treatments: Device: Fibro Scan; Genetic: PNPLA3

Study type: Observational

Funder types: Other

Identifiers

NCT02779946

01EO1501 (Other Grant/Funding Number)

AD2-0401

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

216 participants in 2 patient groups

CHD-positive

Description:

positive tested for coronary artery disease

Treatment:

Device: Fibro Scan

Genetic: PNPLA3

CHD-negative

Description:

negative tested for coronary artery disease

Treatment:

Device: Fibro Scan

Genetic: PNPLA3