search
Back to results

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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transient Elastography (FibroScan), Echosens, Paris, France
Controlled Attenuation Parameter (CAP), Echosens, Paris, France
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nonalcoholic Steatohepatitis (NASH) focused on measuring NASH; coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with mental diseases
  • Pregnancy or lactation
  • Ascites

Sites / Locations

  • Klinikum der J. W. Goethe-UniversitätRecruiting

Outcomes

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%

Full Information

First Posted
July 5, 2012
Last Updated
July 11, 2012
Sponsor
Johann Wolfgang Goethe University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01638832
Brief Title
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
Official Title
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH)
Keywords
NASH; coronary artery disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
572 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Transient Elastography (FibroScan), Echosens, Paris, France
Intervention Type
Device
Intervention Name(s)
Controlled Attenuation Parameter (CAP), Echosens, Paris, France
Primary Outcome Measure Information:
Title
Liver fibrosis scores I-IV (METAVIR)
Description
METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis
Secondary Outcome Measure Information:
Title
Steatosis fibrosis scores I-III
Description
Steatosis scores: 0 = <5% I = 5-33% II = 33-66% III = >66%

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireen Friedrich-Rust, MD
Email
Mireen.Friedrich-Rust@kgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireen Friedrich-Rust, MD
Organizational Affiliation
Klinikum der J. W. Goethe-Universität Frankfurt am Main
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der J. W. Goethe-Universität
City
Frankfurt am Main
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs