Ignite Creation Date:
2024-05-06 @ 12:38 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03819283
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2019-01-10
Brief Title:
NASH and Coronary Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORO-NASH
Brief Summary:
Although the clinical relationship between NAFLDNASH 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 NAFLDNASH 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
Although the clinical relationship between NAFLDNASH 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A01752-53 | OTHER | ANSM | None |