Non-Alcoholic Fatty Liver DiseaseCORO-NASHNCT03819283
NASH and Coronary Disease
A study testing Hepatic evaluation in people with Non-Alcoholic Fatty Liver Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Hepatic evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2019to 19 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Hepatic evaluation
- Keywords
- fatty liver, coronary artery disease, atherosclerosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic evaluationDiagnostic test
Evaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan)
| Study group | Role | What they receive |
|---|---|---|
| Hepatic evaluation | Other | Not described Receives: Diagnostic Test: Hepatic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Visit 2
Secondary outcomes (4)
Severity of the coronary lesions
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.
Measured: Visit 1
Correlation between the histological severity of NAFLD and the severity of coronary lesions
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
Measured: 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
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
Measured: 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
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
Measured: Visit 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start19 Apr 2019
- Primary completion19 Jul 2023 (estimated)
- Study completion19 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cardiometabolism and Nutrition, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819283
- Sponsor's protocol ID
- APHP180013
- Other IDs
- 2018-A01752-53
- Acronym
- CORO-NASH
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of NAFLD in Patients With Symptomatic Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03819283
- Acronym / sponsor ID
- CORO-NASH / APHP180013
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- fatty liver, coronary artery disease, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institute of Cardiometabolism and Nutrition, France
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 19 Jul 2023 (estimated)
- Study completion
- 19 Jul 2024 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic evaluation | Other | Diagnostic Test: Hepatic evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic evaluationEvaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan) | Diagnostic test | Hepatic evaluation |
Primary outcome
NAFLD and significant fibrosis (≥ F2)
Time frame: Visit 2
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).
4 secondary outcomes
Severity of the coronary lesions
Time frame: Visit 1
Correlation between the histological severity of NAFLD and the severity of coronary lesions
Time frame: 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
Time frame: 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
Time frame: Visit 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatic evaluation in people with Non-Alcoholic Fatty Liver Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gérard HELFT, PU-PH (0142162911, gerard.helft@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAFLD and significant fibrosis (≥ F2) (time frame: Visit 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.