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
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease||Diagnostic Test: Hepatic evaluation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Diagnostic Test: Hepatic evaluation
Evaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan)
- 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).
- 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.
- 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
- 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
- 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
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
|Contact: Gérard HELFT, PU-PHemail@example.com|
|Pitié Salpêtrière Hospital||Recruiting|
|Paris, France, 75013|