Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD (Cardio-NASH)

March 5, 2026 updated by: Clinique Pasteur

Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease

This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.

Study Overview

Status

Completed

Conditions

Detailed Description

Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Study Type

Observational

Enrollment (Actual)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13285
        • Hôpital St Joseph
      • Toulouse, France, 31 076
        • Clinique Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female evaluated in a dedicated hepatology day hospital, as part of a first diagnostic workup or follow-up for already known NAFLD

Description

Inclusion Criteria:

  • NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
  • Patient without known heart disease
  • Patient agreeing to participate and who has given his non opposition

Exclusion Criteria:

  • Association with another cause of liver disease
  • Already known coronary artery disease
  • Pregnancy or breastfeeding in progress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary calcium score
Time Frame: At inclusion
Score in Agatston IU of coronary atherosclerosis risk;ranging from 0 to 100 : low risk; 100 to 400 : intermediate risk and > 400 : high risk of coronary atherosclerosis.
At inclusion
Shear wave liver elastography
Time Frame: At inclusion
Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ARFI Hepatic elasticity
Time Frame: At inclusion
Hepatic elasticity assessed by Acoustic radiation force impulse (ARFI) (in kPa) Hepatic elasticity assessed in kPa : <5 Kpa : normal; 5 to 8 kPa : low to moderate fibrosis ; > 8 kPa : advanced fibrosis; >15 kPa : cirrhosis .
At inclusion
Cardiovascular risk
Time Frame: At inclusion
Systemic Coronary Risk Estimation (SCORE) ranging from <1% very low risk to >15% very high risk of cardiovascular mortality
At inclusion
Coronary heart disease
Time Frame: 3 month
Diagnosis of coronary heart disease
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Pasteur

Investigators

  • Principal Investigator: Maeva GUILLAUME, MD, Clinique Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A03423-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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