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

Active, not recruiting

• Conditions: NAFLD

• Registration Number: NCT04774302
• Lead Sponsor: Clinique Pasteur

Brief Summary

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.

Detailed Description

Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Study Start: 2021-03-18
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary calcium score	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.
Shear wave liver elastography	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 Outcome Measures

Name	Time	Method
Coronary heart disease	3 month	Diagnosis of coronary heart disease
ARFI Hepatic elasticity	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 .
Cardiovascular risk	At inclusion	Systemic Coronary Risk Estimation (SCORE) ranging from \<1% very low risk to \>15% very high risk of cardiovascular mortality

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France