The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease (0030-10)

April 5, 2011 updated by: Ziv Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, Israel, 13100
        • Ziv medical center liver unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  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.
  3. 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

Exclusion Criteria:

  1. Acute coronary syndrome presentation:

    • ST segment deviation on ECG and/or
  2. Cardiac troponin elevation.
  3. Chest pain in combination with positive tests for myocardial ischemia
  4. Hemodynamic instability on presentation.
  5. Inability to write inform consent.
  6. Age <18 years.
  7. Participation in an investigational study within the previous 30days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: Nimer Assy, MD, ZIV MEDICAL CENTER, SAFED ISRAEL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

June 6, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0030-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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