Nonalcoholic Fatty Liver Disease0030-10NCT01139632
The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver Disease and Coronary Artery Disease, run by Ziv Hospital at 1 site in Israel.
Trial summary
The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Coronary Artery Disease
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Mar 2011
- 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: 1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease. 2. Male and female 18years or older. Intermediate Risk patients for having significant CAD is defined as: a - chest pain or dyspnea in the presence of negative stress tests; b - the absence of chest pain but positive stress tests; c - the absence of chest pain and of positive stress tests but intermittent arrhythmias. Age <18 years.
Who may be able to join
- Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.
- Male and female 18years or older.
- Able to provide written informed consent.
- Intermediate Risk patients for having significant CAD is defined as:
- chest pain or dyspnea in the presence of negative stress tests;
- the absence of chest pain but positive stress tests;
- the absence of chest pain and of positive stress tests but intermittent arrhythmias
Who cannot join
- Acute coronary syndrome presentation:
- ST segment deviation on ECG and/or
- Cardiac troponin elevation.
- Chest pain in combination with positive tests for myocardial ischemia
- Hemodynamic instability on presentation.
- Inability to write inform consent.
- Age <18 years.
- Participation in an investigational study within the previous 30days.
Trial locations and contacts
1 site in 1 country.
About this study
The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.
Read the detailed description
Background: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of our study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2.
Methods: 60 patients with chest pain and low to intermediate risk for coronary events will undergo Cardiac CT and blood test measurement of enzyme PLA2, markers of inflammation: CRP, MDA(Malondialdehide), Paraoxonase, FFA(Free Fatty Acids), TG(Triglycerids) will performed.
CAD is defined as a stenosis of more than 50% in at least one major coronary artery, unstable plaque defined as low attenuated plaque <30HU and fatty liver defined as difference in liver and spleen attenuation value -10HU by using CT.
Expected results : we expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.
- Keywords
- NAFLD, lP-pla2, Coronary Arthery Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Nimer Assy, MD, Principal investigator, ZIV MEDICAL CENTER, SAFED ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139632
- Sponsor's protocol ID
- 0030-10
- Acronym
- 0030-10
- Status last verified
- Jun 2010
- First submitted
- 6 Jun 2010
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01139632
- Acronym / sponsor ID
- 0030-10 / 0030-10
- Keywords
- NAFLD, lP-pla2, Coronary Arthery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 8 Jun 2010 (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.
The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.
Detailed description
Background: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of our study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2.
Methods: 60 patients with chest pain and low to intermediate risk for coronary events will undergo Cardiac CT and blood test measurement of enzyme PLA2, markers of inflammation: CRP, MDA(Malondialdehide), Paraoxonase, FFA(Free Fatty Acids), TG(Triglycerids) will performed.
CAD is defined as a stenosis of more than 50% in at least one major coronary artery, unstable plaque defined as low attenuated plaque <30HU and fatty liver defined as difference in liver and spleen attenuation value -10HU by using CT.
Expected results : we expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease. 2. Male and female 18years or older. Intermediate Risk patients for having significant CAD is defined as: a - chest pain or dyspnea in the presence of negative stress tests; b - the absence of chest pain but positive stress tests; c - the absence of chest pain and of positive stress tests but intermittent arrhythmias. Age <18 years.
Key inclusion criteria (7 listed)
- Patients at intermediate risk for significant CAD was admitted to the hospital with the diagnosis of chest pain or undergoing elective CT coronarography due to suspection of coronary artery disease.
- Male and female 18years or older.
- Able to provide written informed consent.
- chest pain or dyspnea in the presence of negative stress tests;
- the absence of chest pain but positive stress tests;
Key exclusion criteria (8 listed)
- Acute coronary syndrome presentation:
- Cardiac troponin elevation.
- Chest pain in combination with positive tests for myocardial ischemia
- Hemodynamic instability on presentation.
- Inability to write inform consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
Related trials for Nonalcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
Nimer Assy, MD principal investigator
ZIV MEDICAL CENTER, SAFED ISRAEL
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 Nonalcoholic Fatty Liver Disease and Coronary Artery Disease, run by Ziv Hospital at 1 site in Israel.
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 7 inclusion and 8 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 6 Apr 2011. 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 Israel. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 6 Apr 2011.