Clinical trial NCT01139632: The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease
Official title: The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonalcoholic Fatty Liver Disease
Coronary Artery Disease
Keywords: NAFLD
lP-pla2
Coronary Arthery Disease
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2010-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
affiliation: ZIV MEDICAL CENTER, SAFED ISRAEL
name: Nimer Assy, MD
role: PRINCIPAL_INVESTIGATOR
References: