Back to resultsAssociation 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
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
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
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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