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
Information provided by:
Johann Wolfgang Goethe University Hospitals Identifier:
First received: July 5, 2012
Last updated: July 11, 2012
Last verified: June 2012

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.

Condition Intervention
Nonalcoholic Steatohepatitis (NASH)
Device: Transient Elastography (FibroScan), Echosens, Paris, France
Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Steatosis fibrosis scores I-III [ Designated as safety issue: No ]

    Steatosis scores:

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

Estimated Enrollment: 572
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with mental diseases
  • Pregnancy or lactation
  • Ascites
  Contacts and Locations
Please refer to this study by its identifier: NCT01638832

Contact: Mireen Friedrich-Rust, MD

Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt am Main, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Principal Investigator: Mireen Friedrich-Rust, MD Klinikum der J. W. Goethe-Universität Frankfurt am Main
  More Information

No publications provided Identifier: NCT01638832     History of Changes
Other Study ID Numbers: JWGUHMED1-005
Study First Received: July 5, 2012
Last Updated: July 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
NASH; coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Fatty Liver
Liver Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases processed this record on April 16, 2014