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

July 11, 2012 updated by: Johann Wolfgang Goethe University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

572

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany
        • Recruiting
        • Klinikum der J. W. Goethe-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with mental diseases
  • Pregnancy or lactation
  • Ascites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Liver fibrosis scores I-IV (METAVIR)

METAVIR fibrosis scores:

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Steatosis fibrosis scores I-III

Steatosis scores:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Mireen Friedrich-Rust, MD, Klinikum der J. W. Goethe-Universität Frankfurt am Main

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWGUHMED1-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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