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

Coronary Disease Clinical Trial

— NILS-R-CHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779946
• Other study ID #: AD2-0401
• Secondary ID: 01EO1501
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: June 15, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Elasticity Imaging Techniques
• Fatty Liver
• Heart Diseases
• Liver Diseases
• Myocardial Ischemia
• Non-alcoholic Fatty Liver Disease

Intervention

Device:
• Fibro Scan

Genetic:
• PNPLA3

Locations

Country	Name	City	State
Germany	Leipzig University Medical Center	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Universitätsklinikum Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Fibrocan vs MR-based methods	MRS will be evaluated and correlated to the results of Fibroscan in a subset of patients.	1 year
Secondary	Correlation of NAFLD and intima media thickness	intima media thickness of the common carotid artery is correlated to the Fibroscan results	1 year
Secondary	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