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NCT01638832 Clinical Trial

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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01638832
Other study ID # JWGUHMED1-005
Secondary ID
Status Recruiting
Phase N/A
First received July 5, 2012
Last updated July 11, 2012
Start date June 2012
Est. completion date December 2013

Study information
Verified date June 2012
Source Johann Wolfgang Goethe University Hospitals
Contact Mireen Friedrich-Rust, MD
Email Mireen.Friedrich-Rust@kgu.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 572
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Transient Elastography (FibroScan), Echosens, Paris, France

• Controlled Attenuation Parameter (CAP), Echosens, Paris, France

Locations
Country Name City State
Germany Klinikum der J. W. Goethe-Universität Frankfurt am Main

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Liver fibrosis scores I-IV (METAVIR) METAVIR fibrosis scores:
I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis		 No
Secondary Steatosis fibrosis scores I-III Steatosis scores:
0 = <5% I = 5-33% II = 33-66% III = >66%		 No
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