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

NAFLD Clinical Trial

— Cardio-NASH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774302
• Other study ID #: 2020-A03423-36
• Status: Recruiting
• Start date: March 18, 2021
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Clinique Pasteur
• Contact: Maeva GUILLAUME, MD
• Phone: +33 5 62 21 16 02
• Email: mguillaume[@]clinique-pasteur.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• NAFLD

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary calcium score	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
Primary	Shear wave liver elastography	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	ARFI Hepatic elasticity	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
Secondary	Cardiovascular risk	Systemic Coronary Risk Estimation (SCORE) ranging from <1% very low risk to >15% very high risk of cardiovascular mortality	At inclusion
Secondary	Coronary heart disease	Diagnosis of coronary heart disease	3 month