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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Information provided by:
Johann Wolfgang Goethe University Hospital 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 Hospital:

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

    METAVIR fibrosis scores:

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

Secondary Outcome Measures:
  • Steatosis fibrosis scores I-III

    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   (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
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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 Hospital
Principal Investigator: Mireen Friedrich-Rust, MD Klinikum der J. W. Goethe-Universität Frankfurt am Main
  More Information Identifier: NCT01638832     History of Changes
Other Study ID Numbers: JWGUHMED1-005
Study First Received: July 5, 2012
Last Updated: July 11, 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 processed this record on May 25, 2017