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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Non-alcoholic Fatty Liver Disease; Elasticity Imaging Techniques
• Intervention / Treatment: Device: Fibro Scan; Genetic: PNPLA3

• Study Type: Observational
• Enrollment (Actual): 216

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04103
    • Leipzig University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting for routine angiography of coronary vessles to the Division of cardiology and angiography of the University Hospital Leipzig

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CHD-positive; positive tested for coronary artery disease	Device: Fibro Scan; Genetic: PNPLA3
CHD-negative; negative tested for coronary artery disease	Device: Fibro Scan; Genetic: PNPLA3

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Universitätsklinikum Leipzig
• Investigators: Principal Investigator: Sebastian Beer, MD, Leipzig University Medical Center, IFB AdiposityDiseases

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Liver Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: AD2-0401; 01EO1501 (Other Grant/Funding Number: Federal Ministry of Education and Research (BMBF))