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

Completed

• Conditions: Coronary Disease; Elasticity Imaging Techniques; Non-alcoholic Fatty Liver Disease
• Interventions: Device: Fibro Scan; Genetic: PNPLA3

• Registration Number: NCT02779946
• Lead Sponsor: University of Leipzig

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-23
• Primary Completion: 2017-03
• Status Verified: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHD-positive	Fibro Scan	positive tested for coronary artery disease
CHD-negative	Fibro Scan	negative tested for coronary artery disease
CHD-positive	PNPLA3	positive tested for coronary artery disease
CHD-negative	PNPLA3	negative tested for coronary artery disease

Primary Outcome Measures

Name	Time	Method
Correlation of presence CHD and NAFLD	1 year	Routine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present.

Secondary Outcome Measures

Name	Time	Method
Correlation of severity of CHD and NAFLD	1 year	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.
Fibrocan vs MR-based methods	1 year	MRS will be evaluated and correlated to the results of Fibroscan in a subset of patients.
Correlation of NAFLD and intima media thickness	1 year	intima media thickness of the common carotid artery is correlated to the Fibroscan results
Correlation of NAFLD and other signs of atherosclerosis	1 year	Plaque burden of abdominal aorta and carotid artery will be correlated to the results of Fibroscan.

Trial Locations

Locations (1)

Leipzig University Medical Center; 🇩🇪 Leipzig, Germany