Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01638832
First received: July 5, 2012
Last updated: July 11, 2012
Last verified: June 2012

July 5, 2012
July 11, 2012
June 2012
September 2013   (final data collection date for primary outcome measure)
Liver fibrosis scores I-IV (METAVIR) [ Designated as safety issue: No ]

METAVIR fibrosis scores:

I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis

Same as current
Complete list of historical versions of study NCT01638832 on ClinicalTrials.gov Archive Site
Steatosis fibrosis scores I-III [ Designated as safety issue: No ]

Steatosis scores:

0 = <5% I = 5-33% II = 33-66% III = >66%

Same as current
Not Provided
Not Provided
 
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination:

  • Transient Elastography and Controlled Attenuation Parameter using the FibroScan
  • blood examination including biochemical markers The results of non-invasive liver steatosis and fibrosis measurement are compared with the results of coronary angiogram concerning the presence or absence of coronary artery disease.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Nonalcoholic Steatohepatitis (NASH)
  • Device: Transient Elastography (FibroScan), Echosens, Paris, France
  • Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
572
December 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, 18 years and older
  • Written consent
  • Coronary angiogram planned

Exclusion Criteria:

  • Patients with mental diseases
  • Pregnancy or lactation
  • Ascites
Both
18 Years and older
No
Contact: Mireen Friedrich-Rust, MD Mireen.Friedrich-Rust@kgu.de
Germany
 
NCT01638832
JWGUHMED1-005
No
Not Provided
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Mireen Friedrich-Rust, MD Klinikum der J. W. Goethe-Universität Frankfurt am Main
Johann Wolfgang Goethe University Hospitals
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP