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

NCT02779946 | Completed

• 2 other identifiers: AD2-040101EO1501
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation of severity of CHD and NAFLD

  1 year

• Fibrocan vs MR-based methods

  1 year

• Correlation of NAFLD and intima media thickness

  1 year

• Correlation of NAFLD and other signs of atherosclerosis

  1 year

Study Arms (2)

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

Interventions

Fibro Scan DEVICE

CHD-negative; CHD-positive

PNPLA3 GENETIC

CHD-negative; CHD-positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• informed consent
• age ≥ 18 years
• patients with indication for routine coronary angiography

You may not qualify if:

• transplanted liver
• resection of right liver lobe
• transaminases of \> 5-fold upper limit
• pregnancy or lactation
• choleastasis on ultrasound imaging
• congestive heart failure (EF\<30%, NYHA III or IV, diastolic dysfunction °III or IV
• pacemaker or ICD
• non removable magnetizable metal implants
• claustrophobia

Sponsors & Collaborators

• University of Leipzig: lead
• Universitätsklinikum Leipzig: collaborator

Study Sites (1)

Leipzig University Medical Center

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Coronary Disease; Non-alcoholic Fatty Liver Disease

Interventions

adiponutrin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Sebastian Beer, MD

  Leipzig University Medical Center, IFB AdiposityDiseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Internal Medicine, Principle Investigator

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: May 23, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

DE (1)