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OpenTrials
Completed

NCT Number: NCT02779946

Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease

Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Digestive System Diseases Elasticity Imaging Techniques Fatty Liver Heart Diseases Liver Diseases Myocardial Ischemia Non-Alcoholic Fatty Liver Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leipzig University Medical Center

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent
  • age ≥ 18 years
  • patients with indication for routine coronary angiography

Exclusion criteria

  • transplanted liver
  • resection of right liver lobe
  • transaminases of > 5-fold upper limit
  • pregnancy or lactation
  • choleastasis on ultrasound imaging
  • active malignant or consuming disease 12 month before inclusion
  • congestive heart failure (EF<30%, NYHA III or IV, diastolic dysfunction °III or IV
  • pulmonary hypertension (WHO °III or IV) Exclusion criteria for MR diagnostics
  • pacemaker or ICD
  • non removable magnetizable metal implants
  • claustrophobia

Treatment and study plan

Fibro Scan

Device

PNPLA3

Genetic

Primary outcomes

  1. Correlation of presence CHD and NAFLD

    Time frame: 1 year

    Routine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present.

Secondary outcomes

  1. Correlation of severity of CHD and NAFLD

    Time frame: 1 year

    Correlation of severity of CHD defined by angiography (Multi or Single vessel disease) will be correlated by quantification of liver fibrosis and steatosis on Fibroscan.

  2. Fibrocan vs MR-based methods

    Time frame: 1 year

    MRS will be evaluated and correlated to the results of Fibroscan in a subset of patients.

  3. Correlation of NAFLD and intima media thickness

    Time frame: 1 year

    intima media thickness of the common carotid artery is correlated to the Fibroscan results

  4. Correlation of NAFLD and other signs of atherosclerosis

    Time frame: 1 year

    Plaque burden of abdominal aorta and carotid artery will be correlated to the results of Fibroscan.

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Universitätsklinikum Leipzig

Registry information

Acronym: NILS-R-CHD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 23, 2016
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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