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.
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.
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?
- Conditions
- 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 group | Role | What 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) | |
| controls | Control 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.
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)
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.
- First posted2 Oct 2018
- Study start18 Dec 2011
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Iacobellis, University of Miami
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Fat as Brown Fat in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03693261
- Acronym / sponsor ID
- 20110879
- Conditions
- Coronary Artery Disease
- Keywords
- epicardial fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Dec 2011 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- 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.
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.
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.
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?
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) | – | Procedure: Coronary artery bypass grafting (CABG)Patients with clinically and angiographically established coronary artery disease (CAD) who require CABG, as part of the standard medical care. |
| controls | – | Procedure: Valve replacementControl 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). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Coronary artery bypass grafting (CABG)CABG, as part of the standard medical care | Procedure or surgery | Coronary Artery Disease (CAD) |
| Valve replacementcardiac surgery for aortic or mitral valve replacement as part of their standard medical care | Procedure or surgery | controls |
Primary outcome
EAT thermoregulatory genes
Time frame: 24 hours
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?
1 secondary outcome
Subcutaneous fat genes
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.