NASH and Coronary Disease

NCT03819283 | Unknown

• 2 other identifiers: APHP1800132018-A01752-53
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

fatty liver, coronary artery disease, atherosclerosis

Outcome Measures

Primary Outcomes (1)

• NAFLD and significant fibrosis (≥ F2)

  NAFLD will be defined by the presence of steatosis at ultrasound concomitant with at least one metabolic risk factor among overweight/obesity, type 2 diabetes, dyslipidemia. The severity of NAFLD will be determined by the presence of significant fibrosis (≥F2) by noninvasive measures (either serum markers or transient elastography).

  Visit 2

Secondary Outcomes (4)

• Severity of the coronary lesions

  Visit 1

• Correlation between the histological severity of NAFLD and the severity of coronary lesions

  51 months after the start of the study

• Analyse of clinical factors associated with the severity of coronary lesions according to the presence or absence of NAFLD

  51 months after the start of the study

• Analyse of the metabolomic signature associated with the severity of coronary lesions according to the presence and severity of NAFLD

  Visit 1 and 2

Study Arms (1)

Hepatic evaluation

OTHER

Diagnostic Test: Hepatic evaluation

Interventions

Hepatic evaluation DIAGNOSTIC_TEST

Evaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan)

Hepatic evaluation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institute of Cardiometabolism and Nutrition, France: collaborator

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Gérard HELFT, PU-PH

CONTACT

0142162911; gerard.helft@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 28, 2019
• Study Start: April 19, 2019
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2024
• Last Updated: September 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)