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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
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
  Purpose

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
Investigators
Principal Investigator: Mireen Friedrich-Rust, MD Klinikum der J. W. Goethe-Universität Frankfurt am Main
  More Information

No publications provided

ClinicalTrials.gov 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
Liver Diseases
Fatty Liver
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014