Epicardial FatNCT01344694
Epicardial Fat, Visceral Fat and Coronary Atherosclerosis
An observational study of Epicardial Fat and Visceral Fat, run by Ziv Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Epicardial Fat, Visceral Fat, Atherosclerosis
- What is being tested?
- patient with liver fat and pts. with excess of visceral fat
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ziv MC
Safed, 13100
Nimer Assy, MD, 972-46828442, assy.n@ziv.health.gov.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Epicardial Fat, Visceral Fat, Atherosclerosis
- Being tested
- patient with liver fat, pts. with excess of visceral fat, control
- Keywords
- Epicardial fat, Visceral fat, atherosclerosis, coronary computed tomography angiography, Carotid Doppler ultrasound
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient with liver fatOther
30 patient with liver fat
pts. with excess of visceral fatOther
pts. with excess of visceral fat
controlOther
30 control subjects
| Study group | Role | What they receive |
|---|---|---|
| patient with liver fat | 30 patients with liver fat Receives: Other: patient with liver fat | |
| excess of visceral fat | 50 pts. with excess of visceral fat Receives: Other: pts. with excess of visceral fat | |
| control | 30 control subjects Receives: Other: control |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicardial FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Nimer Assy, md, Principal investigator, Ziv MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344694
- Sponsor's protocol ID
- 0020-11
- Status last verified
- Apr 2011
- First submitted
- 27 Apr 2011
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Epicardial Fat, Visceral Fat Accumulation & Cardiovascular Atherosclerosis
- ClinicalTrials.gov ID
- NCT01344694
- Acronym / sponsor ID
- 0020-11
- Conditions
- Epicardial Fat, Visceral Fat, Atherosclerosis
- Keywords
- Epicardial fat, Visceral fat, atherosclerosis, coronary computed tomography angiography, Carotid Doppler ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient with liver fat | – | Other: patient with liver fat30 patients with liver fat |
| excess of visceral fat | – | Other: pts. with excess of visceral fat50 pts. with excess of visceral fat |
| control | – | Other: control30 control subjects |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient with liver fat30 patient with liver fat | Other | patient with liver fat |
| pts. with excess of visceral fatpts. with excess of visceral fat | Other | excess of visceral fat |
| control30 control subjects | Other | control |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimer Assy, md principal investigator
Ziv MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epicardial Fat and Visceral Fat, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimer Assy, MD (972-46828442, assy.n@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2011.