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

NCT04774302 | Completed

• 1 other identifier: 2020-A03423-36
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 2

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.

Conditions

NAFLD

Keywords

CAC score; Liver fibrosis; Cardiovascular risk; Metabolic syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• ARFI Hepatic elasticity

  At inclusion

• Cardiovascular risk

  At inclusion

• Coronary heart disease

  3 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (2)

Hôpital St Joseph

Marseille, 13285, France

Location

Clinique Pasteur

Toulouse, 31 076, France

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maeva GUILLAUME, MD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: March 18, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2025-06

Locations

FR (2)