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

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ClinicalTrials.gov Identifier: NCT01638832
Recruitment Status : Unknown
Verified June 2012 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : July 12, 2012
Last Update Posted : July 12, 2012
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Nonalcoholic Steatohepatitis (NASH) Device: Transient Elastography (FibroScan), Echosens, Paris, France Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 572 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
Study Start Date : June 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Liver fibrosis scores I-IV (METAVIR)

    METAVIR fibrosis scores:

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

Secondary Outcome Measures :
  1. Steatosis fibrosis scores I-III

    Steatosis scores:

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638832

Contact: Mireen Friedrich-Rust, MD Mireen.Friedrich-Rust@kgu.de

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

ClinicalTrials.gov Identifier: NCT01638832     History of Changes
Other Study ID Numbers: JWGUHMED1-005
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases