Atherosclerosis Clinical Trial
Official title:
Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis
Verified date | January 2011 |
Source | Ziv Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Observational |
Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a
condition carrying a high risk of coronary artery disease. The independent role of Visceral
Fat in cardiovascular risk remains unclear.
Patients with excess of visceral fat and NAFLD patients will have higher prevalence of
coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting
that the presence of visceral fat and/or fatty liver will be considered an important
condition to optimize the cardiovascular risk stratification
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | December 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - excess of visceral fat with the major cardiovascular risk factors for coronary CT, - diagnosis of fatty liver defined by the presence of bright liver echo pattern, absence of alcohol use (<20g/day), - negative serology for hepatitis B or C diagnosis, - negative auto antibodies, - absence of history of another known liver disease, - 30 sex-age-matched individual with cardiovascular risk factors and without NAFLD and without visceral fat will be considered as controls. - Informed consent will be obtained from each individual and the study will be presented to the the local ethics committee. Exclusion Criteria: - subjects with severe obesity (BMI>35), - recent history of acute illness, - clinical history of ischemic heart disease and cerebro vascular disease, - typical chest pain, - previous coronary artery disease, - conventional coronary angiography, - percutaneous interventions, - coronary by pass grafting, - renal failure, - cancer patients, - subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others). - Exclusion criteria for coronary computed tomography angiography will included also the presence of multiple ectopic beats, atrial fibrillation, heart rate more than 75/min despite therapy, severe lung disease, or a history of allergic reaction to iodine-containing contrast agents. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Liver clinic | Safed | |
Israel | Ziv medical center liver unit | Safed, Israel |
Lead Sponsor | Collaborator |
---|---|
Ziv Hospital |
Israel,
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