Epicardial Fat, Visceral Fat and Coronary Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01344694
First received: April 27, 2011
Last updated: May 13, 2011
Last verified: April 2011
  Purpose

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 Intervention
Epicardial Fat
Visceral Fat
Atherosclerosis
Other: patient with liver fat
Other: pts. with excess of visceral fat
Other: control

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Association Between Epicardial Fat, Visceral Fat Accumulation & Cardiovascular Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Estimated Enrollment: 110
Study Start Date: July 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Assy Nimer, Ziv Medical center
ClinicalTrials.gov Identifier: NCT01344694     History of Changes
Other Study ID Numbers: 0020-11
Study First Received: April 27, 2011
Last Updated: May 13, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 16, 2014