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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
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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 Phase
Nonalcoholic Steatohepatitis (NASH) Device: Transient Elastography (FibroScan), Echosens, Paris, France Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France Not Applicable

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





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%




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with mental diseases
  • Pregnancy or lactation
  • Ascites

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


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

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

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases