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Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification

Primary Purpose

Coronary Artery Calcification

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CT Cardiac
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Calcification focused on measuring NAFLD, Calcium score, Liver Fat, Visceral fat, excessive visceral fat, excessive liver fat accumulation, Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with PCI or CABG will be excluded

Sites / Locations

  • Ziv medical center liver unit

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

CT cardiac

Arm Description

the patient will undergo cardiac CT

Outcomes

Primary Outcome Measures

Total calcium score measurement
total calcium score will be measured

Secondary Outcome Measures

Full Information

First Posted
July 4, 2010
Last Updated
April 5, 2011
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01158066
Brief Title
Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification
Official Title
Association Between NAFLD and Coronary Artery Calcification
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ziv Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Coronary artery disease are 8 times more prevalent in patients with NAFLD that 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. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Calcification
Keywords
NAFLD, Calcium score, Liver Fat, Visceral fat, excessive visceral fat, excessive liver fat accumulation, Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT cardiac
Arm Type
No Intervention
Arm Description
the patient will undergo cardiac CT
Intervention Type
Procedure
Intervention Name(s)
CT Cardiac
Intervention Description
the patient will undergo cardiac CT
Primary Outcome Measure Information:
Title
Total calcium score measurement
Description
total calcium score will be measured
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD Exclusion Criteria: Patients with PCI or CABG will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Assy Nimer, MD
Phone
+97246828445
Email
assy.n@ziv.health.gov.il
Facility Information:
Facility Name
Ziv medical center liver unit
City
Safed, Israel
ZIP/Postal Code
13100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimer Assy, MD
Phone
+972-46828445
Email
assy.n@ziv.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification

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