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

Sponsor

Clinique Pasteur (Other)

Overall Status

Recruiting

CT.gov ID

NCT04774302

Collaborator

(none)

300

Enrollment

Location

32.5

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NAFLD

Detailed Description

Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 18, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Pasteur	Toulouse		France	31 076

Sponsors and Collaborators

Clinique Pasteur

Investigators

Principal Investigator: Maeva GUILLAUME, MD, Clinique Pasteur

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Maeva GUILLAUME, Principal investigator, MD, Clinique Pasteur

ClinicalTrials.gov Identifier:

NCT04774302

Other Study ID Numbers:

2020-A03423-36

First Posted:

Mar 1, 2021

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Maeva GUILLAUME, Principal investigator, MD, Clinique Pasteur

Additional relevant MeSH terms:

Fibrosis

Study Results

No Results Posted as of Jul 21, 2022