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

Coronary Artery Disease Clinical Trial

— 0030-10  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01139632
• Other study ID #: 0030-10
• Status: Active, not recruiting
• Phase: N/A
• First received: June 6, 2010
• Last updated: April 5, 2011
• Start date: July 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2010
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 de?ned 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Fatty Liver
• Liver Diseases
• Myocardial Ischemia
• Nonalcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel,