- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01344694
Epicardial Fat, Visceral Fat and Coronary Atherosclerosis
May 13, 2011 updated by: Ziv Hospital
Association Between Epicardial Fat, Visceral Fat Accumulation & Cardiovascular Atherosclerosis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nimer Assy, MD
- Phone Number: 972-46828442
- Email: assy.n@ziv.health.gov.il
Study Contact Backup
- Name: Nimer Assy
- Phone Number: 972-46828442
- Email: assy.n@ziv.health.gov.il
Study Locations
-
-
-
Safed, Israel, 13100
- Ziv MC
-
Contact:
- Nimer Assy, MD
- Phone Number: 972-46828442
- Email: assy.n@ziv.health.gov.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patient with liver fat
30 patients with liver fat
|
30 patient with liver fat
|
excess of visceral fat
50 pts.
with excess of visceral fat
|
pts. with excess of visceral fat
|
control
30 control subjects
|
30 control subjects
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nimer Assy, md, Ziv MC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
February 1, 2012
Study Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
April 27, 2011
First Submitted That Met QC Criteria
April 28, 2011
First Posted (Estimate)
April 29, 2011
Study Record Updates
Last Update Posted (Estimate)
May 16, 2011
Last Update Submitted That Met QC Criteria
May 13, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0020-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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