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Epicardial Fat, Visceral Fat and Coronary Atherosclerosis

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ClinicalTrials.gov Identifier: NCT01344694
Recruitment Status : Unknown
Verified April 2011 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 29, 2011
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear.

Condition or disease Intervention/treatment
Epicardial Fat Visceral Fat Atherosclerosis Other: patient with liver fat Other: pts. with excess of visceral fat Other: control

Detailed Description:
Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear. Aim: Evaluate the link between epicardial fat, visceral fat, liver fat accumulation and cardiovascular diseases and carotis atherosclerosis in patients with the major cardiovascular risk factors and with or without metabolic syndrome.

Study Design

Study Type : Observational
Estimated Enrollment : 110 participants
Time Perspective: Retrospective
Official Title: Association Between Epicardial Fat, Visceral Fat Accumulation & Cardiovascular Atherosclerosis
Study Start Date : July 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
patient with liver fat
30 patients with liver fat
Other: patient with liver fat
30 patient with liver fat
excess of visceral fat
50 pts. with excess of visceral fat
Other: pts. with excess of visceral fat
pts. with excess of visceral fat
control
30 control subjects
Other: control
30 control subjects


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
50 patients (age 40-70) with excess of visceral fat (obese), 30 patient with liver fat and 30 sexes, age matched individuals will be recruited.
Criteria

Inclusion Criteria:

  • Patients referred to cardiac CT will be the source of recruitment.
  • patients with excess of visceral fat,
  • 30 patients with liver fat accumulation
  • 30 sex-age-matched individual (controls) will be enrolled. All patients will undergo a complete family history, personal clinical history, physical examination and blood sampling for biochemical analysis.
  • Informed consent will be obtained from each individual.

Exclusion Criteria:

  • subjects with severe morbid obesity (body mass index [BMI] > 40),
  • recent history of acute illness,
  • clinical history of ischemic heart disease and cerebrovascular 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)
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): NCT01344694


Contacts
Contact: Nimer Assy, MD 972-46828442 assy.n@ziv.health.gov.il
Contact: Nimer Assy 972-46828442 assy.n@ziv.health.gov.il

Locations
Israel
Ziv MC Not yet recruiting
Safed, Israel, 13100
Contact: Nimer Assy, MD    972-46828442    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Nimer Assy, md Ziv MC
More Information

Responsible Party: Dr. Assy Nimer, Ziv Medical center
ClinicalTrials.gov Identifier: NCT01344694     History of Changes
Other Study ID Numbers: 0020-11
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: April 2011

Keywords provided by Ziv Hospital:
Epicardial fat
Visceral fat
atherosclerosis
coronary computed tomography angiography
Carotid Doppler ultrasound

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases