NCT01158066

Brief Summary

Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

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

July 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 6, 2011

Status Verified

June 1, 2010

Enrollment Period

5 months

First QC Date

July 4, 2010

Last Update Submit

April 5, 2011

Conditions

Coronary Artery Calcification

Keywords

NAFLDCalcium scoreLiver FatVisceral fatexcessive visceral fatexcessive liver fat accumulationBiomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)

Outcome Measures

Primary Outcomes (1)

  • Total calcium score measurement

    total calcium score will be measured

    1 month

Study Arms (1)

CT cardiac

NO INTERVENTION

the patient will undergo cardiac CT

Procedure: CT Cardiac

Interventions

CT CardiacPROCEDURE

the patient will undergo cardiac CT

CT cardiac

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD

You may not qualify if:

  • Patients with PCI or CABG will be excluded

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 DiseaseFatty LiverInflammation

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Assy Nimer, MD

CONTACT

+97246828445assy.n@ziv.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 4, 2010

First Posted

July 8, 2010

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

April 6, 2011

Record last verified: 2010-06

Locations

IL(1)