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Coronary Artery DiseaseNCT03693261

Epicardial Fat in Coronary Artery Disease

An observational study of Coronary Artery Disease, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We hypothesize that human epicardial fat plays a thermogenic role to the myocardium. We hypothesize that epicardial fat may express genes of brown fat and thyroid function that are down-regulated by the presence of coronary artery disease. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary artery bypass grafting (CABG) and Valve replacement
Type of treatment
Surgery or procedure
How many people
43 participants
Where
1 siteUnited States
Study dates
18 Dec 2011to 15 Apr 2019
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The total number of patients participating in the research will be 60. The study group will be formed by 50 consecutive patients, male and female, age 50-75 years, Caucasian, Hispanic and African American, patients with clinically and angiographically established CAD who will undergo CABG, as part of their standard medical care. The control group will be formed by 10 subjects male and female age 50-75 years, randomly selected, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care; these patients have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography.

Who may be able to join

  • Subjects with clinically and angiographically established CAD
  • Controls: subjects with have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care

Who cannot join

  • Patients with heart failure, kidney failure or liver failure, infective disease or cancer will be excluded from the study. Subjects taking glucocorticoids or estrogens or patients currently smoking will be excluded from the study. Patients with mental disorders will also not be included

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Epicardial Fat as Brown Fat in Coronary Artery Disease

We hypothesize that human epicardial fat plays a thermogenic role to the myocardium. We hypothesize that epicardial fat may express genes of brown fat and thyroid function that are down-regulated by the presence of coronary artery disease. Because the postulated metabolic role of the epicardial fat, we also hypothesize that the gene expression of these regulatory thermogenic factors is higher in epicardial than subcutaneous fat

This will be a cross-sectional study conducted over a one-year period in patients with or without coronary artery disease who require elective cardiac surgery regardless their participation in the study.

Read more

Study group will be formed by 50 patients with clinically and angiographically established CAD who will undergo coronary artery bypass graft, as part of their standard medical care. Control group will be formed by 10 subjects, randomly selected, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care (these patients have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography).

This will be a cross-sectional study conducted over a one-year period in patients with or without coronary artery disease who require elective cardiac surgery regardless their participation in the study.

Adipose tissue will be collected during the cardiac surgery.

Read the detailed description

Our previous studies indicate that epicardial fat, the visceral fat depot of the heart, plays a role in modulating the heart morphology and its function (Iacobellis et al 2005). Notably, no muscle fascia divides the epicardial fat and the myocardium and the two tissues share the same microcirculation (Iacobellis et al 2005). Epicardial fat has peculiar biochemical properties and is actively involved in lipid and energy homeostasis. Epicardial fat is also a source of several bioactive molecules that might directly influence the myocardium and coronary arteries (Iacobellis et al, 2005,). Because of its anatomic proximity to the myocardium and its intense paracrine and metabolic activity, it is suggested that epicardial fat cytokines reach the myocardium through paracrine or vasocrine pathways and consequently modify its function. Given all these effects and properties, epicardial fat is pathophysiologically and clinically related to development and progression of coronary artery disease and atherosclerosis, regardless of obesity (Iacobellis 2010). Additionally, epicardial fat directly correlates with the intramyocardial lipid content, as we recently described (Malavazos 2010), suggesting a real interaction between the two tissues. However, a dichotomous role has been actually attributed to the epicardial fat. In fact, under physiological conditions epicardial fat displays cardioprotective effects (Iacobellis 2009) and potentially energetic and thermogenic properties, as brown fat (Sacks 2009). Although the interpretation of this finding is still unclear, expression of uncoupling protein1 (UCP1), a marker of brown fat, has been found in human epicardial fat and significantly higher than in subcutaneous fat. We know that brown fat generates heat in response to cold temperatures and activation of the autonomic nervous system under the direct control of thyroid hormones (Bianco 2011). Although the interest in brown fat in humans is growing, our understanding of its actual role in humans is still unclear. The heart is a highly demand organ, under the metabolic control of the thyroid and possibly the epicardial fat. Interestingly experimental models show that hypoxia induces type 3 deiodinase (D3) overexpression in the myocardium that inactivates T3 during ischemia, to protectively decrease cardiomyocytes metabolism and energy expenditure (Simonides et al 2008). Epicardial fat may function like brown fat and thyroid target tissue to protect and defend the myocardium and coronary artery against hypothermia and chronic hypoxia. Nevertheless, whether epicardial fat may have this role and whether this may be affected by the presence of coronary artery disease is currently unknown. We therefore hypothesize that human epicardial fat plays a thermogenic role to the myocardium. We hypothesize that epicardial fat may express genes of brown fat and thyroid function that are downregulated by the presence of coronary artery disease. Because the postulated metabolic role of the epicardial fat, we also hypothesize that the gene expression of these regulatory thermogenic factors is higher in epicardial than subcutaneous fat. These hypotheses will be tested as follows:Specific Aims Ia)Does human epicardial fat express makers of brown adipose tissue, such UCP1 and brown adipocyte differentiation transcription factors in subjects with and without coronary artery disease?b)Does human epicardial fat express type 2 and type 3 deiodinase, thyroid hormones and 3 adrenergic receptors in subjects with and without coronary artery disease?c)Is the thermoregulatory function of the human epicardial fat correlated to the presence and severity of coronary artery disease? Specific Aims IIa)Does the expression of brown fat and thyroid markers gene expression is higher in epicardial than subcutaneous fat?b)Does epicardial fat thickness, as measured by echocardiography, correlate with the gene expression of brown adipose tissue and thyroid markers?c)Does epicardial fat thickness, as measured by echocardiography, correlate with the presence and severity of coronary artery disease?

Being tested
Coronary artery bypass grafting (CABG), Valve replacement
Keywords
epicardial fat
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary artery bypass grafting (CABG)Procedure or surgery

    CABG, as part of the standard medical care

  • Valve replacementProcedure or surgery

    cardiac surgery for aortic or mitral valve replacement as part of their standard medical care

Study groups in NCT03693261
Study groupRoleWhat they receive
Coronary Artery Disease (CAD)Patients with clinically and angiographically established coronary artery disease (CAD) who require CABG, as part of the standard medical care.
Receives: Procedure: Coronary artery bypass grafting (CABG)
controlsControl group will be formed by subjects, randomly selected, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care (these patients have no history, clinical signs of CAD, and show normal coronary arteries on coronary angiography).
Receives: Procedure: Valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EAT thermoregulatory genes

    Does human epicardial fat express makers of brown adipose tissue, such UCP-1 and brown adipocyte differentiation transcription factors in subjects with and without coronary artery disease? Does human epicardial fat express type 2 and type 3 deiodinase, thyroid hormones and β-3 adrenergic receptors in subjects with and without coronary artery disease? Is the thermoregulatory function of the human epicardial fat correlated to the presence and severity of coronary artery disease?

    Measured: 24 hours

Secondary outcomes (1)
  1. Subcutaneous fat genes

    Does the expression of brown fat and thyroid markers gene expression is higher in epicardial than subcutaneous fat?

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start18 Dec 2011
  3. Primary completion15 Apr 2019
  4. Study completion15 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693261
Sponsor's protocol ID
20110879
Status last verified
Apr 2019
First submitted
30 Sep 2018
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by University of Miami at 1 site in United States.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 17 Apr 2019. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EAT thermoregulatory genes (time frame: 24 hours). It is what the study was designed to measure, not a finding.

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 17 Apr 2019.

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