NCT03819283

NASH and Coronary Disease

Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Although the clinical relationship between NAFLD/NASH and cardiovascular (CV) risk is now well established, there is very little awareness of the hepatic disease and the way it may contribute to increased CV risk in patients seen in cardiology clinics for complications of coronary artery disease. Our clinical hypothesis is that NAFLD, possibly at a stage of advanced fibrosis, is common in patients with symptomatic coronary artery disease (CAD) and increases the risk of severe atherosclerotic lesions. The primary aim of this study is to determine (a) the prevalence and (b) the severity spectrum of NAFLD among patients with symptomatic coronary artery disease. The secondary aims are: to analyze the impact of the presence and the severity spectrum of NAFLD (steatosis, steatohepatitis and fibrosis) on the severity of CAD ; To determine the profile of NAFLD patients at risk to develop coronary lesions; To explore the mechanistic link between NAFLD and CAD beyond common metabolic risk factors.

Detailed description

Because of shared metabolic risk factors and pathogenic pathways (insulin resistance, chronic low grade inflammation, atherogenic dyslipidemia) non-alcoholic fatty liver disease is frequently associated with cardiovascular (CV) disease. Despite a lot of transversal studies showing a frequent association between NAFLD and CV disease, it is difficult to determine if NAFLD plays an active role in atherogenesis or is just a marker of common risk factors. Some longitudinal studies, although retrospectives, showed that NAFLD favors the progression of early atherosclerosis, suggesting that NAFLD is an independent CV risk factor beyond the association driven by metabolic syndrome. Although the clinical relationship between NAFLD/NASH and CV risk is now well established, there is very little awareness of the hepatic disease and the way it may contribute to increased CV risk in patients seen in cardiology clinics for complications of coronary artery disease (CAD). Our clinical hypothesis is that NAFLD, possibly at a stage of advanced fibrosis, is common in patients with symptomatic CAD and increases the risk of severe atherosclerotic lesions. The primary aim of this study is to determine (a) the prevalence of NAFLD among patients with symptomatic CAD. The secondary aims are: * To determine the severity spectrum of NAFLD among patients with coronary artery disease. * To analyze the impact of the presence and the severity spectrum of NAFLD (steatosis, steatohepatitis and fibrosis) on the severity of CAD and long term clinical outcomes (ancillary studies) * To determine the clinical profile of NAFLD patients at risk to develop coronary lesions * To explore the mechanistic link between NAFLD and CAD beyond common metabolic risk factors. * Establish a cohort of patients with NAFLD and coronary disease allowing future subsequent ancillary studies.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hepatic evaluation	Evaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan)

Timeline

• Start date: 2019-04-19
• Primary completion: 2023-07-19
• Completion: 2024-07-19
• First posted: 2019-01-28
• Last updated: 2022-09-08

Locations

1 site across 1 country: France