NCT01638832

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
572

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 12, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

July 5, 2012

Last Update Submit

July 11, 2012

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

NASH; coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Liver fibrosis scores I-IV (METAVIR)

    METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis

Secondary Outcomes (1)

  • Steatosis fibrosis scores I-III

Interventions

Transient Elastography (FibroScan), Echosens, Paris, FranceDEVICE
Controlled Attenuation Parameter (CAP), Echosens, Paris, FranceDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with mental diseases
  • Pregnancy or lactation
  • Ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Germany

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mireen Friedrich-Rust, MD

    Klinikum der J. W. Goethe-Universität Frankfurt am Main

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireen Friedrich-Rust, MD

CONTACT

Mireen.Friedrich-Rust@kgu.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 12, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

July 12, 2012

Record last verified: 2012-06

Locations

DE(1)