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OpenTrials
Completed

NCT Number: NCT04774302

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

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.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Fibrosis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Cirrhosis Liver Diseases Metabolic Diseases Metabolic Syndrome Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital St Joseph, Marseille, France

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About this study

Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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 .

  2. 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

  3. Coronary heart disease

    Time frame: 3 month

    Diagnosis of coronary heart disease

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Official study title

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

Acronym: Cardio-NASH

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2021
Registry last updated
Mar 6, 2026

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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