Coronary DiseaseNILS-R-CHDNCT02779946
Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease
An observational study of Coronary Disease and Non-alcoholic Fatty Liver Disease, run by University of Leipzig at 1 site in Germany.
Trial summary
Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Non-alcoholic Fatty Liver Disease, Elasticity Imaging Techniques
- What is being tested?
- Fibro Scan and PNPLA3
- Type of treatment
- Medical device
- How many people
- 216 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Jun 2017
- Phase
- Observational
- 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
Study population: Patients presenting for routine angiography of coronary vessles to the Division of cardiology and angiography of the University Hospital Leipzig
Who may be able to join
- informed consent
- age ≥ 18 years
- patients with indication for routine coronary angiography
Who cannot join
- transplanted liver
- resection of right liver lobe
- transaminases of > 5-fold upper limit
- pregnancy or lactation
- choleastasis on ultrasound imaging
- active malignant or consuming disease 12 month before inclusion
Show all 11Show fewer
- congestive heart failure (EF<30%, NYHA III or IV, diastolic dysfunction °III or IV
- pulmonary hypertension (WHO °III or IV) Exclusion criteria for MR diagnostics
- pacemaker or ICD
- non removable magnetizable metal implants
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.
- Being tested
- Fibro Scan, PNPLA3
- Medical subject headings
- Coronary Disease, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibro ScanDevice
PNPLA3Genetic
| Study group | Role | What they receive |
|---|---|---|
| CHD-positive | positive tested for coronary artery disease Receives: Device: Fibro Scan; Genetic: PNPLA3 | |
| CHD-negative | negative tested for coronary artery disease Receives: Device: Fibro Scan; Genetic: PNPLA3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of presence CHD and NAFLD
Routine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present.
Measured: 1 year
Secondary outcomes (4)
Correlation of severity of CHD and NAFLD
Correlation of severity of CHD defined by angiography (Multi or Single vessel disease) will be correlated by quantification of liver fibrosis and steatosis on Fibroscan.
Measured: 1 year
Fibrocan vs MR-based methods
MRS will be evaluated and correlated to the results of Fibroscan in a subset of patients.
Measured: 1 year
Correlation of NAFLD and intima media thickness
intima media thickness of the common carotid artery is correlated to the Fibroscan results
Measured: 1 year
Correlation of NAFLD and other signs of atherosclerosis
Plaque burden of abdominal aorta and carotid artery will be correlated to the results of Fibroscan.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Leipzig
- Responsible party
- Principal investigator, Sebastian Beer, University of Leipzig
- Investigators
- Sebastian Beer, MD, Principal investigator, Leipzig University Medical Center, IFB AdiposityDiseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779946
- Sponsor's protocol ID
- AD2-0401
- Other IDs
- 01EO1501
- Acronym
- NILS-R-CHD
- Status last verified
- Jun 2017
- First submitted
- 16 Oct 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT02779946
- Acronym / sponsor ID
- NILS-R-CHD / AD2-0401
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Universitätsklinikum Leipzig
- Study start
- Oct 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 May 2016 (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.
Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHD-positive | – | Device: Fibro Scan, Genetic: PNPLA3positive tested for coronary artery disease |
| CHD-negative | – | Device: Fibro Scan, Genetic: PNPLA3negative tested for coronary artery disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for routine angiography of coronary vessles to the Division of cardiology and angiography of the University Hospital Leipzig
Key inclusion criteria (3 listed)
- informed consent
- age ≥ 18 years
- patients with indication for routine coronary angiography
Key exclusion criteria (11 listed)
- transplanted liver
- resection of right liver lobe
- transaminases of > 5-fold upper limit
- pregnancy or lactation
- choleastasis on ultrasound imaging
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 |
|---|---|---|
| Fibro Scan | Device | CHD-negative, CHD-positive |
| PNPLA3 | Genetic | CHD-negative, CHD-positive |
Primary outcome
Correlation of presence CHD and NAFLD
Time frame: 1 year
Routine angiography defines the presents of CHD. Fibroscan will determine whether and to which extent a NAFLD is present.
4 secondary outcomes
Correlation of severity of CHD and NAFLD
Time frame: 1 year
Fibrocan vs MR-based methods
Time frame: 1 year
Correlation of NAFLD and intima media thickness
Time frame: 1 year
Correlation of NAFLD and other signs of atherosclerosis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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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.
Sebastian Beer, MD principal investigator
Leipzig University Medical Center, IFB AdiposityDiseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Non-alcoholic Fatty Liver Disease, run by University of Leipzig 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 11 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: finished, as of the sponsor's last update on 16 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of presence CHD and NAFLD (time frame: 1 year). 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 16 Jun 2017.