Clinical trial NCT03819283: NASH and Coronary Disease
Official title: Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: fatty liver, coronary artery disease, atherosclerosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institute of Cardiometabolism and Nutrition, France
First posted: 2019-01-28
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years old) that undergo coronary angiography for suspected CAD for: acute coronary syndrome (ACS) with ST-elevation ACS (STE-ACS) or non-ST elevation (NSTE-ACS) with or without troponin elevation OR suspicion of stable coronary artery disease after stress imaging techniques and/or symptoms of angina.
* Patients with one or more of traditional cardiovascular risk factors.

Exclusion Criteria:

* Patients unable to sign the informed consent
* Morbidly obese patients (BMI \> 40kg/m2)
* Excessive alcohol consumption of more than 50 g/day
* Patients with known other causes of chronic liver disease (viral hepatitis, autoimmune, hemochromatosis...)
* Active neoplastic pathology
* Pregnant or breastfeeding women
* Protected adults

Primary outcomes:
measure: NAFLD and significant fibrosis (≥ F2)
timeFrame: Visit 2
Secondary outcomes:
measure: Severity of the coronary lesions
timeFrame: Visit 1
measure: Correlation between the histological severity of NAFLD and the severity of coronary lesions
timeFrame: 51 months after the start of the study
measure: Analyse of clinical factors associated with the severity of coronary lesions according to the presence or absence of NAFLD
timeFrame: 51 months after the start of the study
measure: Analyse of the metabolomic signature associated with the severity of coronary lesions according to the presence and severity of NAFLD
timeFrame: Visit 1 and 2
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpêtrière Hospital
Study officials:
References: