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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01158066
Recruitment Status : Unknown
Verified June 2010 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 8, 2010
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Coronary Artery Calcification Procedure: CT Cardiac

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Association Between NAFLD and Coronary Artery Calcification
Study Start Date : August 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: CT cardiac
the patient will undergo cardiac CT
Procedure: CT Cardiac
the patient will undergo cardiac CT


Outcome Measures

Primary Outcome Measures :
  1. Total calcium score measurement [ Time Frame: 1 month ]
    total calcium score will be measured


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158066


Contacts
Contact: Assy Nimer, MD +97246828445 assy.n@ziv.health.gov.il

Locations
Israel
Ziv medical center liver unit Not yet recruiting
Safed, Israel, Israel, 13100
Contact: Nimer Assy, MD    +972-46828445    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Ziv Hospital
More Information

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01158066     History of Changes
Other Study ID Numbers: NAFLD and CAC
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: June 2010

Keywords provided by Ziv Hospital:
NAFLD
Calcium score
Liver Fat
Visceral fat
excessive visceral fat
excessive liver fat accumulation
Biomarkers of insulin resistance (HOMA), inflammation (CRP) and (MDA-Paraoxonase)

Additional relevant MeSH terms:
Non-alcoholic Fatty Liver Disease
Calcinosis
Arteriosclerosis
Coronary Artery Disease
Fatty Liver
Liver Diseases
Digestive System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases