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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02779946
Acronym
NILS-R-CHD
Enrollment
216
Registered
2016-05-23
Start date
2015-10-31
Completion date
2017-06-30
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Non-alcoholic Fatty Liver Disease, Elasticity Imaging Techniques

Brief summary

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.

Interventions

GENETICPNPLA3

Sponsors

Universitätsklinikum Leipzig
CollaboratorOTHER
University of Leipzig
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Correlation of presence CHD and NAFLD1 yearRoutine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present.

Secondary

MeasureTime frameDescription
Correlation of severity of CHD and NAFLD1 yearCorrelation of severity of CHD defined by angiography (Multi or Single vessel disease) will be correlated by quantification of liver fibrosis and steatosis on Fibroscan.
Fibrocan vs MR-based methods1 yearMRS will be evaluated and correlated to the results of Fibroscan in a subset of patients.
Correlation of NAFLD and intima media thickness1 yearintima media thickness of the common carotid artery is correlated to the Fibroscan results
Correlation of NAFLD and other signs of atherosclerosis1 yearPlaque burden of abdominal aorta and carotid artery will be correlated to the results of Fibroscan.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026