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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01158066
First received: July 4, 2010
Last updated: April 5, 2011
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Coronary Artery Calcification
 Procedure: CT Cardiac

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Association Between NAFLD and Coronary Artery Calcification

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Total calcium score measurement [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    total calcium score will be measured


Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CT cardiac
the patient will undergo cardiac CT
 Procedure: CT Cardiac
the patient will undergo cardiac CT

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01158066     History of Changes
Other Study ID Numbers: NAFLD and CAC
Study First Received: July 4, 2010
Last Updated: April 5, 2011
Health Authority: Israel: Ministry of Health

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:
Calcinosis
Fatty Liver
Coronary Artery Disease
Arteriosclerosis
Calcium Metabolism Disorders
Metabolic Diseases
Liver Diseases
 Digestive System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013