NCT01139632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 6, 2011

Status Verified

June 1, 2010

Enrollment Period

6 months

First QC Date

June 6, 2010

Last Update Submit

April 5, 2011

Conditions

Keywords

NAFLDlP-pla2Coronary Arthery Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv medical center liver unit

Safed, Israel, 13100, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Nimer Assy, MD

    ZIV MEDICAL CENTER, SAFED ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 6, 2010

First Posted

June 8, 2010

Study Start

July 1, 2010

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

April 6, 2011

Record last verified: 2010-06

Locations