Nonalcoholic Steatohepatitis (NASH)NCT01638832
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
A study testing Transient Elastography (FibroScan), Echosens, Paris, France in people with Nonalcoholic Steatohepatitis (NASH), run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination: Transient Elastography and Controlled Attenuation Parameter using the FibroScan blood examination including biochemical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- Transient Elastography (FibroScan), Echosens, Paris, France
- Type of treatment
- Medical device
- How many people
- 572 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Dec 2013
- 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
- Male or female, 18 years and older
- Written consent
- Coronary angiogram planned
Who cannot join
- Patients with mental diseases
- Pregnancy or lactation
- Ascites
Trial locations and contacts
1 site in 1 country.
Mireen Friedrich-Rust, MD contact
Germany1 site, 1 recruiting
- Recruiting
Klinikum der J. W. Goethe-Universität
Frankfurt am Main
About this study
This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination:
- Transient Elastography and Controlled Attenuation Parameter using the FibroScan
- blood examination including biochemical markers The results of non-invasive liver steatosis and fibrosis measurement are compared with the results of coronary angiogram concerning the presence or absence of coronary artery disease.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- Transient Elastography (FibroScan), Echosens, Paris, France, Controlled Attenuation Parameter (CAP), Echosens, Paris, France
- Keywords
- NASH; coronary artery disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient Elastography (FibroScan), Echosens, Paris, FranceDevice
Controlled Attenuation Parameter (CAP), Echosens, Paris, FranceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fibrosis scores I-IV (METAVIR)
METAVIR fibrosis scores:
I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis
Secondary outcomes (1)
Steatosis fibrosis scores I-III
Steatosis scores:
0 = <5% I = 5-33% II = 33-66% III = >66%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- 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
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mireen Friedrich-Rust, MD, Principal investigator, Klinikum der J. W. Goethe-Universität Frankfurt am Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638832
- Sponsor's protocol ID
- JWGUHMED1-005
- Status last verified
- Jun 2012
- First submitted
- 5 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01638832
- Acronym / sponsor ID
- JWGUHMED1-005
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Keywords
- NASH; coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Jul 2012 (estimated)
- 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.
This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination:
- Transient Elastography and Controlled Attenuation Parameter using the FibroScan
- blood examination including biochemical markers The results of non-invasive liver steatosis and fibrosis measurement are compared with the results of coronary angiogram concerning the presence or absence of coronary artery disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years and older
- Written consent
- Coronary angiogram planned
Key exclusion criteria (3 listed)
- Patients with mental diseases
- Pregnancy or lactation
- Ascites
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 |
|---|---|---|
| Transient Elastography (FibroScan), Echosens, Paris, France | Device | – |
| Controlled Attenuation Parameter (CAP), Echosens, Paris, France | Device | – |
Primary outcome
Liver fibrosis scores I-IV (METAVIR)
METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis
1 secondary outcome
Steatosis fibrosis scores I-III
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
Mireen Friedrich-Rust, MD contact
Mireen Friedrich-Rust, MD principal investigator
Klinikum der J. W. Goethe-Universität Frankfurt am Main
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transient Elastography (FibroScan), Echosens, Paris, France in people with Nonalcoholic Steatohepatitis (NASH), run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 3 inclusion and 3 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 12 Jul 2012. 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 Germany. 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 Mireen Friedrich-Rust, MD (Mireen.Friedrich-Rust@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fibrosis scores I-IV (METAVIR). 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 12 Jul 2012.