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NASH and Coronary Disease (CORO-NASH)

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ClinicalTrials.gov Identifier: NCT03819283
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Institute of Cardiometabolism and Nutrition, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Diagnostic Test: Hepatic evaluation Not Applicable

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 profile of NAFLD patients at risk to develop coronary lesions
  • To explore the mechanistic link between NAFLD and CAD beyond common metabolic risk factors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease
Actual Study Start Date : April 19, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : November 15, 2020


Arm Intervention/treatment
Hepatic evaluation Diagnostic Test: Hepatic evaluation
Evaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan)




Primary Outcome Measures :
  1. NAFLD and significant fibrosis (≥ F2) [ Time Frame: Up to 6 months ]
    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).


Secondary Outcome Measures :
  1. Severity of the coronary lesions [ Time Frame: Up to 6 months ]
    Based on the results of the coronary angiography, patients will be classified according to the severity of CAD as follows: no CAD, stable CAD (less than 50% stenosis, 1 vessel CAD with > 50% stenosis, 2 vessels CAD with > 50% stenosis, 3 vessels CAD with > 50% stenosis), and acute coronary syndrome.

  2. Correlation between the histological severity of NAFLD and the severity of coronary lesions [ Time Frame: 21 months after the start of the study ]
    The severity of the coronary lesions will be defined as follows : absent, stable coronary lesions (significant >=50% or non significant coronary atheroma), acute coronary syndrome

  3. Analyse of clinical factors associated with the severity of coronary lesions according to the presence or absence of NAFLD [ Time Frame: 21 months after the start of the study ]
    The severity of the coronary lesions will be defined as follows : absent, stable coronary lesions (significant >= 50% or non significant coronary atheroma), acute coronary syndrome

  4. Analyse of the metabolomic signature associated with the severity of coronary lesions according to the presence and severity of NAFLD [ Time Frame: 21 months after the start of the study ]
    The severity of the coronary lesions will be defined as follows : absent, stable coronary lesions (significant >=50%or non significant coronary atheroma), acute coronary syndrome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Patient with a pacemaker
  • Pregnant or breastfeeding women
  • Protected adults

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819283


Contacts
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Contact: Gérard HELFT, PU-PH 0142162911 gerard.helft@aphp.fr

Locations
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France
Pitié Salpêtrière Hospital Recruiting
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institute of Cardiometabolism and Nutrition, France
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03819283    
Other Study ID Numbers: APHP180013
2018-A01752-53 ( Other Identifier: ANSM )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
fatty liver, coronary artery disease, atherosclerosis
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases