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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04774302

Acronym

Cardio-NASH

Enrollment

292

Registered

2021-03-01

Start date

2021-03-18

Completion date

2025-04-30

Last updated

2026-03-06

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

Conditions

NAFLD

Keywords

CAC score, Liver fibrosis, Cardiovascular risk, Metabolic syndrome

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Coronary heart disease	3 month	Diagnosis of coronary heart disease

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMaeva GUILLAUME, MD

Clinique Pasteur

Outcome results