Overview

This trial is active, not recruiting.

Conditions nonalcoholic fatty liver disease, coronary artery disease
Sponsor Ziv Hospital
Start date July 2010
End date January 2011
Trial size 60 participants
Trial identifier NCT01139632, 0030-10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Contribution of Lp-PLA2 Level to the Presence of Coronary Plaques in Patients With Non Alcoholic Fatty Liver Disease
Principal investigator Nimer Assy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Ziv Hospital.